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OpenTrials
Completed

NCT Number: NCT06906809

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

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.

Completed

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc

Madison, Wisconsin, 53704-2526, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BGB-16673

Drug

Administered orally

Itraconazole

Drug

Administered orally

Phenytoin

Drug

Administered orally

Primary outcomes

  1. Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  2. 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

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  3. Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

Secondary outcomes

  1. Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  2. Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  3. Part A and Part B: Apparent Total Clearance (CL/F) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  4. Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  5. Part A and Part B: Number of Participants with Adverse Events (AEs)

    Time frame: 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

  6. Part A and Part B: Number of Participants with Clinically Significant Laboratory Values

    Time frame: Up to approximately 36 days

  7. Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results

    Time frame: Up to approximately 36 days

  8. Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements

    Time frame: Up to approximately 36 days

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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