Healthy Volunteers
Conditions
Keywords
BGB-16673, Drug-drug interactions, Pharmacokinetics
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.
Interventions
Sponsors
BeiGene
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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 | — |
| Part A and Part B: Number of Participants with Clinically Significant Laboratory Values | Up to approximately 36 days | — |
| 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 | — |
Countries
United States
Outcome results
None listed