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Drug Interaction Study of Sonrotoclax

Phase 1

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy males or healthy females of non-childbearing potential

Be between 18 and 65 years old

Must not have

Evidence of renal impairment at screening

Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for part a and approximately 7 weeks for part b

Awards & highlights

Summary

This trial aims to study how the metabolism of a drug called sonrotoclax is affected by other drugs that either increase or decrease the activity of a specific enzyme in the body. The study will be

Who is the study for?

This trial is for healthy volunteers who want to help study the effects of certain drugs on sonrotoclax, a medication being tested. Participants must not have any health conditions that could interfere with the drug's activity or their safety during the trial.

What is being tested?

The study is looking at how sonrotoclax behaves in the body when taken with either phenytoin (Part A) or itraconazole (Part B). These drugs are known to affect how other drugs are broken down by the liver.

What are the potential side effects?

Possible side effects may include reactions related to liver enzyme changes due to phenytoin and itraconazole, which can alter how sonrotoclax is processed in the body. Specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy male or a female who cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidneys are not working properly.

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I cannot take phenytoin or itraconazole due to health reasons.

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I have been treated with sonrotoclax before.

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I am a current smoker or have smoked in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for part a and approximately 7 weeks for part b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for part a and approximately 7 weeks for part b

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for part a and approximately 7 weeks for part b for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Parts A and B: Number of Participants with Adverse Events (AEs)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Itraconazole + SonrotoclaxExperimental Treatment2 Interventions

Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants.

Group II: Part A: Phenytoin + SonrotoclaxExperimental Treatment2 Interventions

Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phenytoin

2023

Completed Phase 4

~900

Itraconazole

2017

Completed Phase 2

~830

0 / 5Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BeiGeneLead Sponsor

188 Previous Clinical Trials

30,055 Total Patients Enrolled

1 Trials studying Not Determined

92 Patients Enrolled for Not Determined

Quotient SciencesIndustry Sponsor

50 Previous Clinical Trials

1,544 Total Patients Enrolled

Study DirectorStudy DirectorBeiGene

1,252 Previous Clinical Trials

504,349 Total Patients Enrolled

~20 spots leftby Sep 2025

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