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

NCT ID: NCT06906809

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2025-10-13

Brief Summary

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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

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Conditions

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Healthy Volunteers

Keywords

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BGB-16673 Drug-drug interactions Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

BGB-16673

Intervention Type DRUG

Administered orally

Phenytoin

Intervention Type DRUG

Administered orally

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

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

Group Type EXPERIMENTAL

BGB-16673

Intervention Type DRUG

Administered orally

Itraconazole

Intervention Type DRUG

Administered orally

Interventions

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BGB-16673

Administered orally

Intervention Type DRUG

Itraconazole

Administered orally

Intervention Type DRUG

Phenytoin

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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Fortrea Clinical Research Unit Inc

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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BGB-16673-105

Identifier Type: -

Identifier Source: org_study_id