Drug-drug InteractionPhase 1NCT03530995
Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers
A Phase 1 study testing Belumosudil, Itraconazole and Rabeprazole in people with Drug-drug Interaction and Autoimmune Diseases, run by Kadmon Corporation, LLC at 1 site in United Kingdom.
Trial summary
This is a single-center, 2-part, non-randomized, open-label study of the drug-drug interactions of belumosudil (KD025) with itraconazole, rifampicin, rabeprazole, and omeprazole in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction, Autoimmune Diseases, Fibrotic Disease
- What is being tested?
- Belumosudil, Itraconazole and Rabeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Apr 2018to 8 Feb 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age 18 to 55 years
- Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), electrocardiogram (ECG) and laboratory investigations (hematology, clinical chemistry, and urinalysis)
- Body weight ≥50 kg
- Body mass index of 18.0 to 32.0 kg/m^2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must adhere to the contraception requirements
Who cannot join
- Subjects who had previously participated in any other investigational study drug trial in which receipt of an IP occurred within 90 days prior to dosing. (Subjects who had previously received belumosudil in Part 1 at least 90 days prior to dosing in Part 2 were eligible to participate.)
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects with pregnant partners
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >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)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission
Show all 31Show fewer
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result at screening and admission
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Subject has a history or presence of any of the following:
- Active gastrointestinal disease requiring therapy
- Hepatic disease and/or alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) > ULN
- Renal disease and/or serum creatinine > ULN
- Other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Subjects with a history of cholecystectomy or gall stones
- Subject has QT interval corrected using Fridericia's formula (QTcF) intervals >450 msec at screening or admission
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients; including intolerance to itraconazole, rabeprazole, and rifampicin
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IP administration.
- Failure to satisfy the investigator of fitness to participate for any other reason
- Subjects Agreed to the Following Restrictions During the Duration of the Study:
- No alcohol during the 24-hour period prior to screening and the 24-hour period prior to admission in Period 1, and 24 hours prior to commencing non-IP treatment in Part 1, Periods 2 to 4 and Part 2, Period 2, until discharge for each treatment period.
- No food or drinks containing grapefruit or cranberry from 24 hours prior to admission in Period 1, and 24 hours prior to commencing non-IP treatment in Part 1 Periods 2 to 4 and Part 2 Period 2, until discharge for each treatment period.
- No food or drinks containing caffeine or other xanthines from 24 hours prior to admission until discharge for each treatment period.
- No food containing poppy seeds for 48 hours prior to screening and for 24 hours prior to admission until discharge for each treatment period.
- No unaccustomed or strenuous exercise from the 72-hour period before the screening visit and then from 24 hours prior to admission until discharge for each treatment period.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences Ltd
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A 2-Part, Non-randomized, Open-label Study to Evaluate the Effect of Itraconazole, Rifampicin, Rabeprazole, and Omeprazole on the Pharmacokinetics of Belumosudil (KD025)
This is a single-center, 2-part, non-randomized, open-label study of the drug-drug interactions of belumosudil (KD025) with itraconazole, rifampicin, rabeprazole, and omeprazole in healthy male subjects.
Read the detailed description
Part 1:
The primary objective of Part 1 of this study is to determine the effect of itraconazole, rifampicin, and rabeprazole on the pharmacokinetics of once daily (QD) orally administered belumosudil in healthy male subjects. Part 1 consists of 4 periods.
In each study period, subjects will receive a single dose of belumosudil, in the fed state. Additionally, in order to assess the effects of inhibition and induction of CYP3A4 and the elevation of gastric pH on belumosudil exposure, subjects will receive multiple doses of perpetrator drugs in Periods 2 to 4; a strong CYP3A4 inhibitor, itraconazole, in Period 2; a proton pump inhibitor, rabeprazole, in Period 3; and a strong CYP3A4 inducer, rifampicin, in Period 4.
Subjects will receive a total of 4 single oral dosses of investigative product (IP), 200 mg belumosudil QD, in the fed state over 4 periods (each lasting 3 days with a minimum washout of 2, 8, and 4 days following completion of Periods 1, 2, and 3, respectively). Subjects also will receive 9 single oral doses of itraconazole 200 mg (QD over 9 days) in Period 2; 7 single oral doses of rabeprazole 20 mg (BID over 3 days followed by QD on 1 day) in Period 3; and 9 single doses of rifampicin 600 mg (QD over 9 days) in Period 4.
A follow-up visit will take place 3 to 5 days post-final discharge.
Part 2:
The primary objective of Part 2 of this study is to determine the effect of omeprazole on the PK of a single-day twice daily (BID; every 12 hours [Q12h]) dose of belumosudil administered orally, in healthy male subjects. Part 2 consists of 2 periods.
In Period 1, subjects will receive a single dose of belumosudil, in the fed state. In Period 2, in order to assess the effects of inhibition and induction of CYP3A4 and the elevation of gastric pH on belumosudil exposure, subjects will receive multiple doses of a proton pump inhibitor, omeprazole.
Subjects will receive a total of 4 single oral doses of IP (200 mg belumosudil, BID [Q12h] on 2 occasions) in the fed state over 2 periods (each lasting 3 days with a minimum washout of 2 days between dosing in Period 1 and the start of dosing with non-IP in Period 2). Subjects will also receive 4 single oral doses of omeprazole 20 mg (QD over 4 days) in Period 2.
A follow-up visit will take place 3 to 5 days post-final discharge.
- Conditions
- Drug-drug Interaction, Autoimmune Diseases, Fibrotic Disease
- Being tested
- Belumosudil, Itraconazole, Rabeprazole, Rifampicin, Omeprazole
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
Also called Rezurock, SLx-2119
Development candidate
ItraconazoleDrug
Perpetrator drug
RabeprazoleDrug
Perpetrator drug
RifampicinDrug
Perpetrator drug
OmeprazoleDrug
Perpetrator drug
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Period 1 | Experimental | Drug: Belumosudil. Subjects will receive belumosudil 200 mg single dose on Day 1 Receives: Drug: Belumosudil |
| Part 1, Period 2 | Experimental | Drug: Itraconazole. Subjects will receive itraconazole 200 mg QD on Day 1 through Day 7.
Drug: Belumosudil. Subjects will receive belumosudil 200 mg + itraconazole 200 mg QD on Day 8 Subjects will receive itraconazole 200 mg QD on Day 9 Receives: Drug: Belumosudil; Drug: Itraconazole |
| Part 1, Period 3 | Experimental | Drug: Rabeprazole. Subjects will receive rabeprazole 20 mg BID on Day 1 through Day 3.
Drug: Belumosudil. Subjects will receive belumosudil 200 mg + rabeprazole 20 mg QD on Day 4. Receives: Drug: Belumosudil; Drug: Rabeprazole |
| Part 1, Period 4 | Experimental | Drug: Rifampicin. Subjects will receive rifampicin 600 mg QD on Day 1 through Day 9.
Drug: Belumosudil. Subjects will receive belumosudil 200 mg on Day 10. Receives: Drug: Belumosudil; Drug: Rifampicin |
| Part 2, Period 1 | Experimental | Drug: Belumosudil. Subjects will receive belumosudil 200 mg BID on Day 1. Receives: Drug: Belumosudil |
| Part 2, Period 2 | Experimental | Drug: Omeprazole. Subjects will receive omeprazole 20 mg QD on Day 1 through Day 3.
Drug: Belumosudil. Subjects will receive belumosudil 200 mg BID + omeprazole 20 mg QD on Day 4. Receives: Drug: Belumosudil; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Cmax of KD025 and KD025m2 in Part 1
Maximum concentration (Cmax) of the parent drug, KD025, Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) for belumosudil alone, belumosudil + itraconazole, belumosudil + rabeprazole, and belumosudil + rifampicin at 0 to 48 hours post-dose
Measured: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose
Pharmacokinetics: Cmax of KD025m1 in Part 1
Maximum concentration (Cmax) of Metabolite 1 (KD025m1) for belumosudil alone and for belumosudil + rifampicin up to 48 hours post-dose
Measured: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Maximum concentration (Cmax) of the parent drug (KD025), for Metabolite 1 (KD025m1), and for Metabolite 2 (KD025m2), for belumosudil alone and for belumosudil + omeprazole up to 48 hours post-dose
Measured: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dose
Pharmacokinetics: AUC(0-inf) and AUC(0-24) of KD025 and KD025 m2 for Subject in Part 1 and Part 2
Area under concentration-time curve from zero hours to infinity (AUC[0-inf]) and from zero hours to 24 hours post-dose (AUC[0-24)) for the parent drug KD025, and Metabolite 2, KD025m2, for subjects up to 48 hours each for Part 1 and for Part 2
Measured: Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dose
Pharmacokinetics: AUC(0-24) of KD025m1 for Part 1 and for Part 2
Area under concentration-time curve from zero hours to 24 hours post-dose (AUC[0-24]) for Metabolite 1, KD025m1, for subjects in Part 1 and for subjects in Part 2
Measured: Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12, and 24 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22, and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start9 Apr 2018
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-drug InteractionStudies of the same condition, open and under way.
- 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
- Model description
- Two-Part, Non-Randomised
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530995
- Sponsor's protocol ID
- KD025-107
- Other IDs
- 2018-000316-16, 2018
- Status last verified
- May 2022
- First submitted
- 13 Apr 2018
- Last updated
- 25 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schueller O, Willson A, Singh N, Lohmer L, Alabanza A, Patel J. A Phase 1 Pharmacokinetic Drug Interaction Study of Belumosudil Coadministered With CYP3A4 Inhibitors and Inducers and Proton Pump Inhibitors. Clin Pharmacol Drug Dev. 2022 Jul;11(7):795-806. doi: 10.1002/cpdd.1082. Epub 2022 Mar 1.
PubMed 35230741
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part, Non-randomized, Open-label Study to Evaluate the Effect of Itraconazole, Rifampicin, Rabeprazole, and Omeprazole on the Pharmacokinetics of Belumosudil (KD025)
- ClinicalTrials.gov ID
- NCT03530995
- Acronym / sponsor ID
- KD025-107
- Conditions
- Drug-drug Interaction, Autoimmune Diseases, Fibrotic Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, 2-part, non-randomized, open-label study of the drug-drug interactions of belumosudil (KD025) with itraconazole, rifampicin, rabeprazole, and omeprazole in healthy male subjects.
Detailed description
Part 1:
The primary objective of Part 1 of this study is to determine the effect of itraconazole, rifampicin, and rabeprazole on the pharmacokinetics of once daily (QD) orally administered belumosudil in healthy male subjects. Part 1 consists of 4 periods.
In each study period, subjects will receive a single dose of belumosudil, in the fed state. Additionally, in order to assess the effects of inhibition and induction of CYP3A4 and the elevation of gastric pH on belumosudil exposure, subjects will receive multiple doses of perpetrator drugs in Periods 2 to 4; a strong CYP3A4 inhibitor, itraconazole, in Period 2; a proton pump inhibitor, rabeprazole, in Period 3; and a strong CYP3A4 inducer, rifampicin, in Period 4.
Subjects will receive a total of 4 single oral dosses of investigative product (IP), 200 mg belumosudil QD, in the fed state over 4 periods (each lasting 3 days with a minimum washout of 2, 8, and 4 days following completion of Periods 1, 2, and 3, respectively). Subjects also will receive 9 single oral doses of itraconazole 200 mg (QD over 9 days) in Period 2; 7 single oral doses of rabeprazole 20 mg (BID over 3 days followed by QD on 1 day) in Period 3; and 9 single doses of rifampicin 600 mg (QD over 9 days) in Period 4.
A follow-up visit will take place 3 to 5 days post-final discharge.
Part 2:
The primary objective of Part 2 of this study is to determine the effect of omeprazole on the PK of a single-day twice daily (BID; every 12 hours [Q12h]) dose of belumosudil administered orally, in healthy male subjects. Part 2 consists of 2 periods.
In Period 1, subjects will receive a single dose of belumosudil, in the fed state. In Period 2, in order to assess the effects of inhibition and induction of CYP3A4 and the elevation of gastric pH on belumosudil exposure, subjects will receive multiple doses of a proton pump inhibitor, omeprazole.
Subjects will receive a total of 4 single oral doses of IP (200 mg belumosudil, BID [Q12h] on 2 occasions) in the fed state over 2 periods (each lasting 3 days with a minimum washout of 2 days between dosing in Period 1 and the start of dosing with non-IP in Period 2). Subjects will also receive 4 single oral doses of omeprazole 20 mg (QD over 4 days) in Period 2.
A follow-up visit will take place 3 to 5 days post-final discharge.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Two-Part, Non-Randomised
| Arm | Type | Receives |
|---|---|---|
| Part 1, Period 1 | Experimental | Drug: BelumosudilDrug: Belumosudil. Subjects will receive belumosudil 200 mg single dose on Day 1 |
| Part 1, Period 2 | Experimental | Drug: Belumosudil, Drug: ItraconazoleDrug: Itraconazole. Subjects will receive itraconazole 200 mg QD on Day 1 through Day 7. Drug: Belumosudil. Subjects will receive belumosudil 200 mg + itraconazole 200 mg QD on Day 8 Subjects will receive itraconazole 200 mg QD on Day 9 |
| Part 1, Period 3 | Experimental | Drug: Belumosudil, Drug: RabeprazoleDrug: Rabeprazole. Subjects will receive rabeprazole 20 mg BID on Day 1 through Day 3. Drug: Belumosudil. Subjects will receive belumosudil 200 mg + rabeprazole 20 mg QD on Day 4. |
| Part 1, Period 4 | Experimental | Drug: Belumosudil, Drug: RifampicinDrug: Rifampicin. Subjects will receive rifampicin 600 mg QD on Day 1 through Day 9. Drug: Belumosudil. Subjects will receive belumosudil 200 mg on Day 10. |
| Part 2, Period 1 | Experimental | Drug: BelumosudilDrug: Belumosudil. Subjects will receive belumosudil 200 mg BID on Day 1. |
| Part 2, Period 2 | Experimental | Drug: Belumosudil, Drug: OmeprazoleDrug: Omeprazole. Subjects will receive omeprazole 20 mg QD on Day 1 through Day 3. Drug: Belumosudil. Subjects will receive belumosudil 200 mg BID + omeprazole 20 mg QD on Day 4. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males
- Age 18 to 55 years
- Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), electrocardiogram (ECG) and laboratory investigations (hematology, clinical chemistry, and urinalysis)
- Body weight ≥50 kg
- Body mass index of 18.0 to 32.0 kg/m^2 or, if outside the range, considered not clinically significant by the investigator
Key exclusion criteria (31 listed)
- Subjects who had previously participated in any other investigational study drug trial in which receipt of an IP occurred within 90 days prior to dosing. (Subjects who had previously received belumosudil in Part 1 at least 90 days prior to dosing in Part 2 were eligible to participate.)
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects with pregnant partners
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >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)
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 |
|---|---|---|
| BelumosudilAlso: Rezurock, SLx-2119Development candidate | Drug | Part 1, Period 1, Part 1, Period 2, Part 1, Period 3, Part 1, Period 4, Part 2, Period 1, Part 2, Period 2 |
| ItraconazolePerpetrator drug | Drug | Part 1, Period 2 |
| RabeprazolePerpetrator drug | Drug | Part 1, Period 3 |
| RifampicinPerpetrator drug | Drug | Part 1, Period 4 |
| OmeprazolePerpetrator drug | Drug | Part 2, Period 2 |
Primary outcome
Pharmacokinetics: Cmax of KD025 and KD025m2 in Part 1
Time frame: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose
Maximum concentration (Cmax) of the parent drug, KD025, Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) for belumosudil alone, belumosudil + itraconazole, belumosudil + rabeprazole, and belumosudil + rifampicin at 0 to 48 hours post-dose
Pharmacokinetics: Cmax of KD025m1 in Part 1
Time frame: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose
Maximum concentration (Cmax) of Metabolite 1 (KD025m1) for belumosudil alone and for belumosudil + rifampicin up to 48 hours post-dose
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Time frame: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dose
Maximum concentration (Cmax) of the parent drug (KD025), for Metabolite 1 (KD025m1), and for Metabolite 2 (KD025m2), for belumosudil alone and for belumosudil + omeprazole up to 48 hours post-dose
Pharmacokinetics: AUC(0-inf) and AUC(0-24) of KD025 and KD025 m2 for Subject in Part 1 and Part 2
Time frame: Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dose
Area under concentration-time curve from zero hours to infinity (AUC[0-inf]) and from zero hours to 24 hours post-dose (AUC[0-24)) for the parent drug KD025, and Metabolite 2, KD025m2, for subjects up to 48 hours each for Part 1 and for Part 2
Pharmacokinetics: AUC(0-24) of KD025m1 for Part 1 and for Part 2
Time frame: Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12, and 24 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22, and 24 hours post-dose
Area under concentration-time curve from zero hours to 24 hours post-dose (AUC[0-24]) for Metabolite 1, KD025m1, for subjects in Part 1 and for subjects in Part 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35230741Schueller O, Willson A, Singh N, Lohmer L, Alabanza A, Patel J. A Phase 1 Pharmacokinetic Drug Interaction Study of Belumosudil Coadministered With CYP3A4 Inhibitors and Inducers and Proton Pump Inhibitors. Clin Pharmacol Drug Dev. 2022 Jul;11(7):795-806. doi: 10.1002/cpdd.1082. Epub 2022 Mar 1.
- Individual participant dataSharing planned: No
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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 Belumosudil, Itraconazole and Rabeprazole in people with Drug-drug Interaction and Autoimmune Diseases, run by Kadmon Corporation, LLC at 1 site in United Kingdom.
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 8 inclusion and 31 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 25 May 2022. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pharmacokinetics: Cmax of KD025 and KD025m2 in Part 1 (time frame: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose). The study lists 5 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 NCT03530995, which also lists 1 linked publication.
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 25 May 2022.