Clinical trial NCT06906809: Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
Official title: A Phase 1, Open-label, Fixed-sequence, Crossover Study to Investigate the Effect of Coadministration of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-16673 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BGB-16673
Drug-drug interactions
Pharmacokinetics
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
timeFrame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
measure: 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
timeFrame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
measure: Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673
timeFrame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Secondary outcomes:
measure: Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673
timeFrame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
measure: Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673
timeFrame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
measure: Part A and Part B: Apparent Total Clearance (CL/F) of BGB-16673
timeFrame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
measure: Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-16673
timeFrame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
measure: Part A and Part B: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 36 days
measure: Part A and Part B: Number of Participants with Clinically Significant Laboratory Values
timeFrame: Up to approximately 36 days
measure: Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results
timeFrame: Up to approximately 36 days
measure: Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements
timeFrame: Up to approximately 36 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research Unit Inc
state: Wisconsin
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: