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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BGB-16673; Drug: Phenytoin; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06906809

BGB-16673-105

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Phenytoin

Drug: BGB-16673

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

Experimental group

Description:

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

Treatment:

Drug: Itraconazole

Drug: BGB-16673