Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
Phase 1
Recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06906809
- Lead Sponsor
- BeiGene
- Brief Summary
The purpose of this study is to investigate the effect of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Male or female, of any race, between 18 and 65 years of age
- In good health, as determined by no clinically significant findings from medical history,12- lead ECG and vital signs measurements, physical examination and clinical laboratory evaluations
- Body mass index between 18.0 and 32.0kg/m2, inclusive
Exclusion Criteria
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
- Evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study drug, as determined by the investigator (or designee).
- History of malignancy, except for appropriately treated carcinoma in situ of the cervix or nonmelanoma skin carcinoma not requiring ongoing systemic treatment.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
- Participants who have acute gastrointestinal symptoms at the time of screening and or/admission (eg, nausea, vomiting, diarrhea, or heartburn).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A: BGB-16673 + Phenytoin (CYP3A Inducer) BGB-16673 Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673 Part A: BGB-16673 + Phenytoin (CYP3A Inducer) Phenytoin Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673 Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) BGB-16673 Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673 Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) Itraconazole Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673
- Primary Outcome Measures
Name Time Method Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673 Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673 Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673 Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
- Secondary Outcome Measures
Name Time Method Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673 Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673 Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 Part A and Part B: Apparent Total Clearance (CL/F) of BGB-16673 Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-16673 Part A: Day 1 and Day 20; Part B: Day 1 and Day 17 Part A and Part B: Number of Participants with Adverse Events (AEs) Up to approximately 36 days Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Part A and Part B: Number of Participants with Clinically Significant Laboratory Values Up to approximately 36 days Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results Up to approximately 36 days Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements Up to approximately 36 days
Related Research Topics
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Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc
🇺🇸Madison, Wisconsin, United States