A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
Completed · Phase 1
Conditions studied: Not Determined
In brief
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.
Key facts
- Study ID
- NCT06543043
- Run by
- BeiGene
- People needed
- 30
- Starts
- 2024-08-19
- Expected to finish
- 2024-11-07
- Last updated by the study team
- 2024-11-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Quotient Sciences — Miami, Florida, United States
Full record on ClinicalTrials.gov
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