Status:
COMPLETED
A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
Lead Sponsor:
BeiGene
Collaborating Sponsors:
Quotient Sciences
Conditions:
Not Determined
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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),...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06543043
Start Date
August 19 2024
End Date
November 7 2024
Last Update
November 27 2024
Active Locations (1)
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1
Quotient Sciences
Miami, Florida, United States, 33126