Cardiovascular DiseasePhase 1NCT04686591

Absolute Bioavailability and ADME Study of [14C]AZD9977 in Healthy Male Subjects

A Phase 1 study testing AZD9977 capsule 50 mg, [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL) and [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq) in people with Cardiovascular Disease, run by AstraZeneca at 1 site in United Kingdom.

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

Study to Assess the Absorption, Metabolism, and Excretion of [14C]AZD9977 after a Single-Dose Oral Administration Read more about this study

Who is it for?: Ages 30 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease
What is being tested?: AZD9977 capsule 50 mg, [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL) and [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited Kingdom
Study dates: 21 Dec 2020to 4 Feb 2021
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 30 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects aged 30 to 60 years at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture.
Body mass index (BMI) of 18.0 to 30.0 kg/m2 (body weight at least 50 kg), as measured at screening.
Must be willing and able to communicate and participate in the whole study.
Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day).
Must agree to adhere to the contraception requirements defined in the clinical protocol

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the investigator, 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 gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Clinically significant history of recent depression, seizures or other hyperactive central nervous system condition or ongoing treatment for the same.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9977 or the formulation excipients. Hay fever is allowed unless it is active.
Acute diarrhoea or constipation in the 7 days before administration of IMP in the study. If screening occurs >7 days before the first study day, this criterion will be determined on the first study day.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.

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Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator.
Serum potassium >5.0 mmol/L or fasting blood glucose > upper limit of normal (ULN) at screening.
Evidence of renal impairment at screening, as indicated by an estimated eGFR of <80 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or other evidence of renal impairment.
Subjects with known Gilbert's Syndrome or elevated unconjugated hyperbilirubinaemia or subjects with a history of cholecystectomy or gall stones.
Abnormal resting vital signs (after 5 min rest) of supine systolic BP >140 mmHg and/or diastolic BP >90 mmHg and/or <50 mmHg and/or HR <45 or >90 bpm at screening or Period 1 Day 1 pre-dose. Vital signs can be repeated once if abnormal, as judged by the investigator.
Subjects with clinically significant history of recurrent syncope/blackouts or previous history of orthostatic hypotension or those who are noted to have a fall in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg or elevation in HR of more than 30 bpm when checked between 2 and 5 min after change of posture at screening or at Period 1 Day 1 pre-dose.
Any clinically significant abnormalities on 12-lead ECG, including those which can increase the risk of arrhythmias including QTcF>450 msec, as judged by the investigator.
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and human immunodeficiency virus (HIV) antibody.
Known or suspected history of drug abuse in the past 2 years, as judged by the investigator.
Has received another new chemical entity (defined as a compound which has not been approved for marketing; including radiolabelled chemical entity) within 90 days of Day 1 in this study. The period of exclusion lasts for 90 days after the final dose or 1 month after the last visit whichever is the longest. Note: subjects consented and screened, but not administered IMP in this study or a previous Phase I study, are not excluded.
Involvement of any AstraZeneca, Quotient Sciences or study site employee or their close relatives.
Subjects who report to have previously received AZD9977.
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 6 months prior to screening. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
Positive screen for drugs of abuse at screening or admission to the clinical unit or confirmed positive alcohol breath test at screening or admission to the clinical unit.
Known or suspected history of alcohol abuse or excessive intake of alcohol >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g., >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
Use of any prescribed or non-prescribed medication including antacids, histamine receptor 2 (H2) antagonists, proton pump inhibitors and analgesics (other than up to 4 g paracetamol/acetaminophen per day), herbal remedies (including but not limited to, St. John's wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto and ginseng), megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the two weeks prior to the first administration of IMP or longer if the medication has a long half-life. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
Evidence of current SARS-CoV-2 infection.
Subjects with pregnant or lactating partners.
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
Subjects who have been administered IMP in an 14C ADME study in the last 12 months.
Subjects who cannot communicate reliably with the investigator.
Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Judgment by the investigator that the volunteer should not participate in the study if they have any ongoing or recent (i.e., 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.
Failure to satisfy the investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
Ruddington, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase I, Open-label Study of Absolute Bioavailability and Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]AZD9977 in Healthy Male Subjects

Study to Assess the Absorption, Metabolism, and Excretion of [14C]AZD9977 after a Single-Dose Oral Administration

Conditions: Cardiovascular Disease
Being tested: AZD9977 capsule 50 mg, [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL), [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)
Keywords: Chronic Heart Failure
Medical subject headings: Cardiovascular Diseases

What participants receive

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

AZD9977 capsule 50 mgDrug
Also called AZD9977
100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capusles)
[14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL)Drug
Also called [14C]AZD9977
One 100 µg dose of [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL)
[14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)Drug
Also called [14C]AZD9977
One 100 mg dose of [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)

Study groups in NCT04686591
Study group	Role	What they receive
AZD9977	Experimental	In Period 1, one 100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capsules) and one 100 µg dose of [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL). In Period 2, one 100 mg dose of [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq). Receives: Drug: AZD9977 capsule 50 mg; Drug: [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL); Drug: [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)

What is being measured

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

Absolute bioavailability of AZD9977
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
Measured: Collection of plasma samples from pre-dose until 72 hours post-dose.
The cumulative amount of AZD9977 excreted (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD9977 excreted (CumAe)
Measured: Collection of urine and faecal samples from pre-dose until 168 hours post-dose.
The cumulative amount of AZD9977 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of the rates and routes of elimination by measuring the cumulative amount excreted and expressed as a percentage of the administered dose (CumFe)
Measured: Collection of urine and faecal samples from pre-dose until 168 hours post-dose.
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of plasma samples from pre-dose until 72 hours post-dose in period 1 and from pre-dose to 168 hours post-dose in period 2.
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of urine samples from pre-dose until 72 hours post-dose in period 1 and from pre-dose to 168 hours post-dose in period 2.
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of faecal samples from pre-dose until 168 hours post-dose.

Secondary outcomes (18)

Number of adverse events (AEs) experienced by subjects
Safety and tolerability assessed through the incidence of AEs
Measured: Approximately 8 weeks
Time prior to the first measurable concentration (AZD9977) (tlag)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 and total radioactivity by measuring the time to first measurable concentration (tlag)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Time of maximum observed concentration (tmax)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 and total radioactivity by measuring time of maximum observed concentration (tmax)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Maximum observed concentration (cmax)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 and total radioactivity by measuring maximum observed concentration (cmax)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 and total radioactivity by measuring area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Area under the curve from time 0 extrapolated to infinity (AUC0-inf)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 by measuring area under the curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extrap)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 and total radioactivity by measuring area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extrap)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Terminal half-life (t1/2)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 and total radioactivity by measuring terminal half-life (t1/2)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
First order rate constant associated with the terminal (log-linear) portion of the curve (λz)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 and total radioactivity by measuring first order rate constant associated with the terminal (log-linear) portion of the curve (λz)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Total body clearance calculated after a single oral administration (AZD9977) (CL/F)
Assessment of pharmacokinetics of AZD9977 by measuring total body clearance calculated after a single oral administration (AZD9977) (CL/F)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Renal clearance calculated using plasma AUC (AZD9977 and [14C]AZD9977) (CLr)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 by measuring Renal clearance calculated using plasma AUC (AZD9977 and [14C]AZD9977) (CLr)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Apparent volume of distribution based on the terminal phase calculated using AUC0 inf after a single oral administration (AZD9977) (Vz/F)
Assessment of pharmacokinetics of AZD9977 by measuring apparent volume of distribution based on the terminal phase calculated using AUC0 inf after a single oral administration (AZD9977) (Vz/F)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Mean residence time from time 0 to time of the last measurable concentration (AZD9977 and [14C]AZD9977) (MRT0-t)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 by measuring mean residence time from time 0 to time of the last measurable concentration (AZD9977 and [14C]AZD9977) (MRT0-t)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Mean residence time extrapolated to infinity (AZD9977 and [14C]AZD9977) (MRT0-inf)
Assessment of pharmacokinetics of AZD9977 and [14C]AZD9977 by measuring mean residence time extrapolated to infinity (AZD9977 and [14C]AZD9977) (MRT0-inf)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Total body clearance calculated after a single intravenous administration ([14C]AZD9977) (CL)
Assessment of pharmacokinetics of [14C]AZD9977 by measuring total body clearance calculated after a single intravenous administration ([14C]AZD9977) (CL)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose
Volume of distribution at steady state after a single intravenous administration ([14C]AZD9977) (Vss)
Assessment of pharmacokinetics of [14C]AZD9977 by measuring volume of distribution at steady state after a single intravenous administration ([14C]AZD9977) (Vss)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose
Volume of distribution based on the terminal phase calculated using AUC0 inf after a single intravenous administration ([14C]AZD9977) (Vz
Assessment of pharmacokinetics of [14C]AZD9977 by measuring volume of distribution based on the terminal phase calculated using AUC0 inf after a single intravenous administration ([14C]AZD9977) (Vz)
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Assessment of total radioactivity in whole blood and plasma
Measured: Collection of blood samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.

Timeline

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

21 Dec 20204 Feb 2021

First posted29 Dec 2020
Study start21 Dec 2020
Primary completion4 Feb 2021
Study completion4 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseaseStudies 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: Crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04686591
Sponsor's protocol ID: D6402C00002
Status last verified: Mar 2021
First submitted: 17 Dec 2020
Last updated: 9 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label Study of Absolute Bioavailability and Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]AZD9977 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04686591
Acronym / sponsor ID: D6402C00002
Conditions: Cardiovascular Disease
Keywords: Chronic Heart Failure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Quotient Sciences
Study start: 21 Dec 2020 (actual)
Primary completion: 4 Feb 2021 (actual)
Study completion: 4 Feb 2021 (actual)
First posted: 29 Dec 2020 (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.

Study to Assess the Absorption, Metabolism, and Excretion of [14C]AZD9977 after a Single-Dose Oral Administration

Study design

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

Arm	Type	Receives
AZD9977	Experimental	Drug: AZD9977 capsule 50 mg, Drug: [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL), Drug: [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)In Period 1, one 100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capsules) and one 100 µg dose of [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL). In Period 2, one 100 mg dose of [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq).

Who may qualify

Ages: 30 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects aged 30 to 60 years at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture.
Body mass index (BMI) of 18.0 to 30.0 kg/m2 (body weight at least 50 kg), as measured at screening.
Must be willing and able to communicate and participate in the whole study.
Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day).

Key exclusion criteria (32 listed)

History of any clinically significant disease or disorder which, in the opinion of the investigator, 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 gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Clinically significant history of recent depression, seizures or other hyperactive central nervous system condition or ongoing treatment for the same.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9977 or the formulation excipients. Hay fever is allowed unless it is active.
Acute diarrhoea or constipation in the 7 days before administration of IMP in the study. If screening occurs >7 days before the first study day, this criterion will be determined on the first study day.

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
AZD9977 capsule 50 mgAlso: AZD9977100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capusles)	Drug	AZD9977
[14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL)Also: [14C]AZD9977One 100 µg dose of [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL)	Drug	AZD9977
[14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)Also: [14C]AZD9977One 100 mg dose of [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)	Drug	AZD9977

Primary outcome

Absolute bioavailability of AZD9977
Time frame: Collection of plasma samples from pre-dose until 72 hours post-dose.
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
The cumulative amount of AZD9977 excreted (CumAe)
Time frame: Collection of urine and faecal samples from pre-dose until 168 hours post-dose.
Assessment of the total radioactivity by measuring the cumulative amount of AZD9977 excreted (CumAe)
The cumulative amount of AZD9977 excreted and expressed as a percentage of the administered dose (CumFe)
Time frame: Collection of urine and faecal samples from pre-dose until 168 hours post-dose.
Assessment of the rates and routes of elimination by measuring the cumulative amount excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of plasma samples from pre-dose until 72 hours post-dose in period 1 and from pre-dose to 168 hours post-dose in period 2.
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of urine samples from pre-dose until 72 hours post-dose in period 1 and from pre-dose to 168 hours post-dose in period 2.
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of faecal samples from pre-dose until 168 hours post-dose.
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry

18 secondary outcomes

Number of adverse events (AEs) experienced by subjects
Time frame: Approximately 8 weeks
Time prior to the first measurable concentration (AZD9977) (tlag)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Time of maximum observed concentration (tmax)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Maximum observed concentration (cmax)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Area under the curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC%extrap)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Terminal half-life (t1/2)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
First order rate constant associated with the terminal (log-linear) portion of the curve (λz)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Total body clearance calculated after a single oral administration (AZD9977) (CL/F)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Renal clearance calculated using plasma AUC (AZD9977 and [14C]AZD9977) (CLr)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Apparent volume of distribution based on the terminal phase calculated using AUC0 inf after a single oral administration (AZD9977) (Vz/F)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Mean residence time from time 0 to time of the last measurable concentration (AZD9977 and [14C]AZD9977) (MRT0-t)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Mean residence time extrapolated to infinity (AZD9977 and [14C]AZD9977) (MRT0-inf)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.
Total body clearance calculated after a single intravenous administration ([14C]AZD9977) (CL)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Volume of distribution at steady state after a single intravenous administration ([14C]AZD9977) (Vss)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Volume of distribution based on the terminal phase calculated using AUC0 inf after a single intravenous administration ([14C]AZD9977) (Vz
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Time frame: Collection of blood samples from pre-dose to 72 hours post-dose in period 1 and pre-dose to 168 hours post-dose in period 2.

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 9 Mar 2021.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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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.

Somasekhara Menakuru, MBBS, MS, MRCS, DPM principal investigator

Quotient Sciences

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

Questions about this trial

What is this clinical trial studying?

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 9 Mar 2021. 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 Kingdom. 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?

Absolute bioavailability of AZD9977 (time frame: Collection of plasma samples from pre-dose until 72 hours post-dose.). The study lists 6 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 NCT04686591.

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 9 Mar 2021.