CompletedPhase 1

A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

United States30 participantsStarted 2024-08-19

Plain-language summary

This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to understand and sign a written informed consent * Able and willing to comply with all study requirements * Healthy males or healthy females of non-childbearing potential * Agrees to use an adequate method of contraception * Body mass index (BMI) of 18.0 to 32.0 kg/m\^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator. Exclusion Criteria: * Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results * Prior treatment with sonrotoclax * Evidence of renal impairment at screening * Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B) * Current smokers and those who have smoked within the last 12 months * Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months * History of any drug or alcohol abuse in the past 2 years * Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients * History of clinically significant disorders as judged by the investigator Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax

Timeframe: Approximately 21 days for Part A and 11 days for Part B

Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax

Timeframe: Approximately 21 days for Part A and 11 days for Part B

Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax

Timeframe: Approximately 21 days for Part A and 11 days for Part B

Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax

Timeframe: Approximately 21 days for Part A and 11 days for Part B

Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax

Timeframe: Approximately 21 days for Part A and 11 days for Part B

Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax

Timeframe: Approximately 21 days for Part A and 11 days for Part B

Trial details

NCT IDNCT06543043

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-08

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