Solid TumourPhase 1NCT04121910

A Study to Evaluate the Amount of Drug That Becomes Available in the Blood Circulation When Savolitinib is Administered Alone and in Combination With Itraconazole

A Phase 1 study testing Savolitinib and Itraconazole in people with Solid Tumour, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will be conducted to quantify the magnitude of the effect of itraconazole co-administration on the PK of savolitinib. The exposure to savolitinib is predicted to increase when co-administered with the potent cytochrome P (CYP) 3A4 inhibitor itraconazole since CYP3A4 (via CYP450) is involved in the… Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Solid Tumour
What is being tested?: Savolitinib and Itraconazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 7 Nov 2019to 12 Jan 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects with suitable veins for cannulation or repeated venipuncture: non-Japanese male subjects aged 18 to 65 years (inclusive).
Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Alanine aminotransferase, aspartate aminotransferase and total bilirubin within normal limits for the institution at screening and Day -1.
Have a calculated creatinine clearance greater than 60 mL/min using the Cockcroft-Gault formula at Screening.
Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in the protocol.

Who cannot join

Healthy subjects of Japanese ethnicity and any healthy subject that has 1 parent or grandparent (maternal or paternal) of Japanese ethnicity.
History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
History or presence of GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Planned in-patient surgery, dental procedure or hospitalisation during the study.
Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the PI.

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Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Abnormal vital signs, after 5 minutes supine rest at screening and Day -1, defined as any of the following:
Systolic BP <90 mmHg or ≥140 mmHg (2) Diastolic BP <50 mmHg or ≥90 mmHg (3) Heart rate <45 or >85 beats per minute (BPM) 9) Any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead resting ECG that may interfere with the interpretation of QTc interval changes.
These include healthy subjects with any of the following:
Abnormal ST-T-wave morphology, particularly in the protocol defined primary lead (V2) or left ventricular hypertrophy.
PR interval shortening <120 ms (PR >110 ms but <120 ms is acceptable if there is no evidence of ventricular pre-excitation).
PR interval prolongation (>200 ms). Intermittent second (Type 1 second degree block [Wenckebach Phenomenon] while asleep is not exclusive]) or third degree atrioventricular (AV) block, or AV dissociation.
Persistent or intermittent complete bundle branch block (BBB), incomplete BBB, or intraventricular conduction delay with QRS >110 ms. Subjects with QRS >110 ms but <115 ms are acceptable if there is no evidence of eg, ventricular hypertrophy or pre-excitation.
Mean resting prolonged QTcF > 450 ms or shortened QTcF < 340 ms obtained from 3 ECGs.
10) A history of additional risk factors for torsades de pointes (TdP) (eg, chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause TdP).
11) Known or suspected history of drug abuse, as judged by the PI. 12) Current smokers or those who have smoked or used nicotine products within the previous 30 days.
13) History of alcohol abuse or excessive intake of alcohol as judged by the PI.
14) Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate,) as judged by the PI.
15) Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of the IMP.
16) Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first admission on Study Day -1.
17) Use of any prescribed or non-prescribed medication including antacids, analgesics (other than use of ibuprofen) up to 72 hours before first dosing day until final follow-up visit, herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer (5 times half-life) if the medication has a long half-life.
18) Positive screen for drugs of abuse, cotinine (nicotine) and/or alcohol at screening or on each admission to the study centre .
19) History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to savolitinib or itraconazole.
20) Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
21) Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 ½ lives (whichever is longer) of the first administration of IMP in this study.
Note: subjects consented and screened, but not randomized in this study or a previous Phase I study, are not excluded.
22) Involvement of any AstraZeneca, Parexel, or study centre employee or their close relatives 23) Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
24) Subjects who are vegans, vegetarians or have medical dietary restrictions. 25) Subjects who cannot communicate reliably with the PI. 26) Vulnerable subjects, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
27) Subjects who have previously received savolitinib.
In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
28) Previous bone marrow transplant. 29) Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Glendale, California, 91206

Other trials in United States

About this study

Official title: An Open-label, 3-period Fixed-sequence Study in Healthy Subjects to Assess the Pharmacokinetics (PK) of Savolitinib When Administered Alone and in Combination With Itraconazole

Read the detailed description

This study will be an open-label, 3-period, fixed-sequence study in non-Japanese healthy male subjects conducted at a single study centre.

The study will comprise:

A screening period of maximum 28 days;
Three treatment periods:
Treatment Period 1 consists of 15 days with admission on Study Day -1, followed by a single dose administration of savolitinib on Study Day 1 followed by a washout period of at least 14 days. Subjects will be discharged from the study centre on Day 3, after the last PK sample is collected.
Treatment Period 2 consists of 4 days with admission on Study Day 14, followed by itraconazole administration for 3 days (200 mg BID on Study Day 15, 200 mg QD on Study Days 16 and 17).
Treatment Period 3 consists of 3 days, starting immediately after the end of Treatment Period 2 comprising of single dose administration of savolitinib (200 mg) on Study Day 18 and itraconazole administration (200 mg QD) on Study Days 18 and 19. The subjects will be discharged from the study centre on Study Day 20 after the last PK sample.
The Follow-up Visit will occur at least 14 days after the last dose of savolitinib PK sample in Treatment Period 3.
Subjects will be admitted to the study centre on 2 different occasions: Study Day-1 (Study Day -1) to Study Day 3 of Treatment Period 1 and Day -1 (Study Day 14) of Treatment Period 2 to Day 3 (Study Day 20) of Treatment Period 3.

The study drugs will be administered as follows:

Treatment Period 1: Single administration of savolitinib (200 mg) will occur on Study Day 1 after a high-fat, high-calorie breakfast followed by PK sampling for 48 hours.
Treatment Period 2: Itraconazole administered BID (200 mg BID) on Study Day 15, and (200 mg QD) on Study Days 16 and 17, 1 hour before breakfast (and before dinner, when applicable).
Treatment Period 3: A single combination of itraconazole (200 mg) 1 hour before breakfast + savolitinib (200 mg) after a high-fat, high-calorie breakfast on Study Day 18, and a single dose of itraconazole (200 mg) on Study Day 19, 1 hour before breakfast.

Each subject will be involved in the study for up to 60 days.

Conditions: Solid Tumour
Being tested: Savolitinib, Itraconazole
Keywords: Pharmacokinetics, Safety, Small molecule kinase inhibitor, Open-label

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SavolitinibDrug
On Study Day 1 and Study Day 18, savolitinib will be administered as single dose after a high-fat, high-calorie breakfast
ItraconazoleDrug
Twice daily on first day of dosing (Study Day 15) followed by once daily for 4 days (Study Day 16 - Study Day 19) administered 1 hour before any breakfast (and 1 hour before dinner on Study Day 15)

Study groups in NCT04121910
Study group	Role	What they receive
Savolitinib and/or Itraconazole	Experimental	Treatment Period 1: Single administration of savolitinib (200 mg) will occur on Study Day 1 after a high-fat, high-calorie breakfast followed by PK sampling for 48 hours Treatment Period 2: Itraconazole will be administered (200 mg BID) on Study Day 15, and (200 mg QD) on Study Days 16 and 17, 1 hour before breakfast (and before dinner, when applicable) Treatment Period 3: A single combination of itraconazole (200 mg) 1 hour before breakfast + savolitinib (200 mg) after a high-fat, high-calorie breakfast on Study Day 18, and a single dose of itraconazole (200 mg) on Study Day 19, 1 hour before breakfast Receives: Drug: Savolitinib; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Savolitinib area under plasma concentration-time curve from time zero to infinity (AUC) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
To assess the effect of itraconazole on the PK of savolitinib
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib maximum observed plasma concentration (Cmax) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
To assess the effect of itraconazole on the PK of savolitinib
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.

Secondary outcomes (51)

Savolitinib:Area under the plasma concentration-curve from time zero to time of last quantifiable concentration [AUC(0-t)] ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
To assess the effect of itraconazole on the pharmacokinetics of metabolites M2 and M3
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
M2 and M3: Cmax ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
To assess the effect of itraconazole on the pharmacokinetics of metabolites M2 and M3
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
M2 and M3: AUC ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
To assess the effect of itraconazole on the pharmacokinetics of metabolites M2 and M3
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
M2 and M3: AUC(0-t) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
To assess the effect of itraconazole on the pharmacokinetics of metabolites M2 and M3
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: Cmax
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: AUC
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: AUC(0-t)
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: tmax
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: t½,λz
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: λz
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib: CL/F
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib: Vz/F
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Metabolite-to-parent ratios (MRCmax)
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Metabolite-to-parent ratios (MRAUC)
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Metabolite-to-parent ratios [MRAUC(0-t)]
To describe the PK parameters and the PK profiles for savolitinib, M2 and M3 when savolitinib is administered alone and in combination with itraconazole
Measured: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Number of subjects with adverse events
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in systolic blood pressure (BP)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: Screening (Day -28), treatment period 1 (Study Day -1 and 1 to 14) and treatment period 3 (Study Day 1 to 3)
Number of subjects with abnormal findings in diastolic BP
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: Screening (Day -28), treatment period 1 (Study Day -1 and 1 to 14) and treatment period 3 (Study Day 1 to 3)
Number of subjects with abnormal findings in pulse rate
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: Screening (Day -28), treatment period 1 (Study Day -1 and 1 to 14) and treatment period 3 (Study Day 1 to 3)
Number of subjects with abnormal findings in electrocardiogram (ECG)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: Screening (Day -28), treatment period 1 (Days 1 to 14), treatment period 3 (Days 1 to 3) and follow-up visit (At least 14 days after last savolitinib dose)
Number of subjects with abnormal findings in physical examination
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: Study Day -1, Day 1 (pre-dose) of Treatment Periods 1, 2, and 3 (Study Days 1, 15, and 18)
Number of subjects with abnormal findings in white blood cell (WBC) count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in red blood cell (RBC) count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in hemoglobin (Hb)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in hematocrit (HCT)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in mean corpuscular volume (MCV)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in mean corpuscular hemoglobin (MCH)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in mean corpuscular hemoglobin concentration (MCHC)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in neutrophils absolute count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in lymphocytes absolute count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in monocytes absolute count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in eosinophils absolute count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in basophils absolute count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in platelets
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in reticulocytes absolute count
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in sodium
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in potassium
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in urea
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in creatinine clearence
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: Screening (Day -28 to Day -1)
Number of subjects with abnormal findings in albumin
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in calcium
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in phosphate
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in glucose (fasting)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in C-reactive protein (CRP)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in alkaline phosphatase (ALP)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in alanine aminotransferase (ALT)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in aspartate aminotransferase (AST)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in gamma glutamyl transpeptidase (GGT)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in total bilirubin (TBL)
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in unconjugated bilirubin
To assess the safety and tolerability of savolitinib in combination with itraconazole
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in urinalysis
To assess the safety and tolerability of savolitinib in combination with itraconazole The parameters assessed will be glucose, protein and blood
Measured: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 201912 Jan 2020

First posted10 Oct 2019
Study start7 Nov 2019
Primary completion12 Jan 2020
Study completion12 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumourStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04121910
Sponsor's protocol ID: D5084C00002
Status last verified: Jan 2020
First submitted: 9 Oct 2019
Last updated: 23 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumour trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, 3-period Fixed-sequence Study in Healthy Subjects to Assess the Pharmacokinetics (PK) of Savolitinib When Administered Alone and in Combination With Itraconazole
ClinicalTrials.gov ID: NCT04121910
Acronym / sponsor ID: D5084C00002
Conditions: Solid Tumour
Keywords: Pharmacokinetics, Safety, Small molecule kinase inhibitor, Open-label
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 7 Nov 2019 (actual)
Primary completion: 12 Jan 2020 (actual)
Study completion: 12 Jan 2020 (actual)
First posted: 10 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will be an open-label, 3-period, fixed-sequence study in non-Japanese healthy male subjects conducted at a single study centre.

The study will comprise:

A screening period of maximum 28 days;
Three treatment periods:
Treatment Period 1 consists of 15 days with admission on Study Day -1, followed by a single dose administration of savolitinib on Study Day 1 followed by a washout period of at least 14 days. Subjects will be discharged from the study centre on Day 3, after the last PK sample is collected.
Treatment Period 2 consists of 4 days with admission on Study Day 14, followed by itraconazole administration for 3 days (200 mg BID on Study Day 15, 200 mg QD on Study Days 16 and 17).
Treatment Period 3 consists of 3 days, starting immediately after the end of Treatment Period 2 comprising of single dose administration of savolitinib (200 mg) on Study Day 18 and itraconazole administration (200 mg QD) on Study Days 18 and 19. The subjects will be discharged from the study centre on Study Day 20 after the last PK sample.
The Follow-up Visit will occur at least 14 days after the last dose of savolitinib PK sample in Treatment Period 3.
Subjects will be admitted to the study centre on 2 different occasions: Study Day-1 (Study Day -1) to Study Day 3 of Treatment Period 1 and Day -1 (Study Day 14) of Treatment Period 2 to Day 3 (Study Day 20) of Treatment Period 3.

The study drugs will be administered as follows:

Treatment Period 1: Single administration of savolitinib (200 mg) will occur on Study Day 1 after a high-fat, high-calorie breakfast followed by PK sampling for 48 hours.
Treatment Period 2: Itraconazole administered BID (200 mg BID) on Study Day 15, and (200 mg QD) on Study Days 16 and 17, 1 hour before breakfast (and before dinner, when applicable).
Treatment Period 3: A single combination of itraconazole (200 mg) 1 hour before breakfast + savolitinib (200 mg) after a high-fat, high-calorie breakfast on Study Day 18, and a single dose of itraconazole (200 mg) on Study Day 19, 1 hour before breakfast.

Each subject will be involved in the study for up to 60 days.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Savolitinib and/or Itraconazole	Experimental	Drug: Savolitinib, Drug: ItraconazoleTreatment Period 1: Single administration of savolitinib (200 mg) will occur on Study Day 1 after a high-fat, high-calorie breakfast followed by PK sampling for 48 hours Treatment Period 2: Itraconazole will be administered (200 mg BID) on Study Day 15, and (200 mg QD) on Study Days 16 and 17, 1 hour before breakfast (and before dinner, when applicable) Treatment Period 3: A single combination of itraconazole (200 mg) 1 hour before breakfast + savolitinib (200 mg) after a high-fat, high-calorie breakfast on Study Day 18, and a single dose of itraconazole (200 mg) on Study Day 19, 1 hour before breakfast

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects with suitable veins for cannulation or repeated venipuncture: non-Japanese male subjects aged 18 to 65 years (inclusive).
Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Alanine aminotransferase, aspartate aminotransferase and total bilirubin within normal limits for the institution at screening and Day -1.
Have a calculated creatinine clearance greater than 60 mL/min using the Cockcroft-Gault formula at Screening.

Key exclusion criteria (32 listed)

Healthy subjects of Japanese ethnicity and any healthy subject that has 1 parent or grandparent (maternal or paternal) of Japanese ethnicity.
History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
History or presence of GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Planned in-patient surgery, dental procedure or hospitalisation during the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SavolitinibOn Study Day 1 and Study Day 18, savolitinib will be administered as single dose after a high-fat, high-calorie breakfast	Drug	Savolitinib and/or Itraconazole
ItraconazoleTwice daily on first day of dosing (Study Day 15) followed by once daily for 4 days (Study Day 16 - Study Day 19) administered 1 hour before any breakfast (and 1 hour before dinner on Study Day 15)	Drug	Savolitinib and/or Itraconazole

Primary outcome

Savolitinib area under plasma concentration-time curve from time zero to infinity (AUC) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
To assess the effect of itraconazole on the PK of savolitinib
Savolitinib maximum observed plasma concentration (Cmax) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
To assess the effect of itraconazole on the PK of savolitinib

51 secondary outcomes

Savolitinib:Area under the plasma concentration-curve from time zero to time of last quantifiable concentration [AUC(0-t)] ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
M2 and M3: Cmax ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
M2 and M3: AUC ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
M2 and M3: AUC(0-t) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: Cmax
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: AUC
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: AUC(0-t)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: tmax
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: t½,λz
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib, M2 and M3: λz
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib: CL/F
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Savolitinib: Vz/F
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Metabolite-to-parent ratios (MRCmax)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Metabolite-to-parent ratios (MRAUC)
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Metabolite-to-parent ratios [MRAUC(0-t)]
Time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.
Number of subjects with adverse events
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in systolic blood pressure (BP)
Time frame: Screening (Day -28), treatment period 1 (Study Day -1 and 1 to 14) and treatment period 3 (Study Day 1 to 3)
Number of subjects with abnormal findings in diastolic BP
Time frame: Screening (Day -28), treatment period 1 (Study Day -1 and 1 to 14) and treatment period 3 (Study Day 1 to 3)
Number of subjects with abnormal findings in pulse rate
Time frame: Screening (Day -28), treatment period 1 (Study Day -1 and 1 to 14) and treatment period 3 (Study Day 1 to 3)
Number of subjects with abnormal findings in electrocardiogram (ECG)
Time frame: Screening (Day -28), treatment period 1 (Days 1 to 14), treatment period 3 (Days 1 to 3) and follow-up visit (At least 14 days after last savolitinib dose)
Number of subjects with abnormal findings in physical examination
Time frame: Study Day -1, Day 1 (pre-dose) of Treatment Periods 1, 2, and 3 (Study Days 1, 15, and 18)
Number of subjects with abnormal findings in white blood cell (WBC) count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in red blood cell (RBC) count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in hemoglobin (Hb)
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in hematocrit (HCT)
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in mean corpuscular volume (MCV)
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in mean corpuscular hemoglobin (MCH)
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in mean corpuscular hemoglobin concentration (MCHC)
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in neutrophils absolute count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in lymphocytes absolute count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in monocytes absolute count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in eosinophils absolute count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in basophils absolute count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in platelets
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in reticulocytes absolute count
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in sodium
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in potassium
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in urea
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)
Number of subjects with abnormal findings in creatinine clearence
Time frame: Screening (Day -28 to Day -1)
Number of subjects with abnormal findings in albumin
Time frame: From Screening (Day -28) up to the Follow-up visit (at least 14 days after savolitinib dose)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Individual participant dataSharing planned: No

Related trials for Solid Tumour

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Savolitinib and Itraconazole in people with Solid Tumour, run by AstraZeneca at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Savolitinib area under plasma concentration-time curve from time zero to infinity (AUC) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone) (time frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04121910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.