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

NCT ID: NCT06543043

Last Updated: 2024-11-27

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2024-11-07

Brief Summary

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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.

Detailed Description

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Conditions

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Not Determined

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part A: Phenytoin + Sonrotoclax

Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.

Group Type EXPERIMENTAL

Phenytoin

Intervention Type DRUG

Administered orally.

sonrotoclax

Intervention Type DRUG

Administered orally.

Part B: Itraconazole + Sonrotoclax

Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants.

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

Administered orally.

sonrotoclax

Intervention Type DRUG

Administered orally.

Interventions

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Phenytoin

Administered orally.

Intervention Type DRUG

Itraconazole

Administered orally.

Intervention Type DRUG

sonrotoclax

Administered orally.

Intervention Type DRUG

Other Intervention Names

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BGB-11417

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign a written informed consent
* Able and willing to comply with all study requirements
* Healthy males or healthy females of non-childbearing potential
* Agrees to use an adequate method of contraception
* Body mass index (BMI) of 18.0 to 32.0 kg/m\^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.

Exclusion Criteria

* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
* Prior treatment with sonrotoclax
* Evidence of renal impairment at screening
* Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
* Current smokers and those who have smoked within the last 12 months
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* History of any drug or alcohol abuse in the past 2 years
* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
* History of clinically significant disorders as judged by the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quotient Sciences

INDUSTRY

Sponsor Role collaborator

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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Quotient Sciences

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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QSC302214

Identifier Type: OTHER

Identifier Source: secondary_id

BGB-11417-107

Identifier Type: -

Identifier Source: org_study_id