Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants

NCT06906809 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-16673-105
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

BGB-16673; Drug-drug interactions; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (2)

Part A: BGB-16673 + Phenytoin (CYP3A Inducer)

EXPERIMENTAL

Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673

Drug: BGB-16673; Drug: Phenytoin

Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor)

EXPERIMENTAL

Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673

Drug: BGB-16673; Drug: Itraconazole

Interventions

BGB-16673 DRUG

Administered orally

Part A: BGB-16673 + Phenytoin (CYP3A Inducer); Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor)

Itraconazole DRUG

Administered orally

Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor)

Phenytoin DRUG

Administered orally

Part A: BGB-16673 + Phenytoin (CYP3A Inducer)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc

Madison, Wisconsin, 53704-2526, United States

Location

MeSH Terms

Interventions

Itraconazole; Phenytoin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Hydantoins; Imidazolidines; Imidazoles

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 3, 2025
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)