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A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

NCT06543043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-27

No results posted yet for this study

Summary

This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.

Conditions

  • Not Determined

Interventions

DRUG

Phenytoin

Administered orally.

DRUG

Itraconazole

Administered orally.

DRUG

sonrotoclax

Administered orally.

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2024-10-08
Completion
2024-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06543043 on ClinicalTrials.gov