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

Conditions

• Not Determined

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Phenytoin — DRUG
  Administered orally.
• Itraconazole — DRUG
  Administered orally.
• sonrotoclax — DRUG
  Administered orally.

Study Details

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.

Key Dates

Start date

Aug 19, 2024

Status verified

Nov 2024

Primary completion

Oct 8, 2024

Completion

Nov 7, 2024

Study Design

Enrollment

30 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Part A: Phenytoin + Sonrotoclax
  Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.
• Experimental: Part B: Itraconazole + Sonrotoclax
  Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants.

Primary Outcome Measure

Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax [ Time Frame: Approximately 21 days for Part A and 11 days for Part B ]

Locations (1)

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