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

NCT06543043 | Completed Phase 1 FDA Drug

• 2 other identifiers: BGB-11417-107QSC302214
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sonrotoclax; BGB-11417; healthy volunteers; phenytoin; itraconazole

Outcome Measures

Primary Outcomes (9)

• Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

• Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax

  Approximately 21 days for Part A and 11 days for Part B

Secondary Outcomes (1)

• Parts A and B: Number of Participants with Adverse Events (AEs)

  From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B

Study Arms (2)

Part A: Phenytoin + Sonrotoclax

EXPERIMENTAL

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

Drug: Phenytoin; Drug: sonrotoclax

Part B: Itraconazole + Sonrotoclax

EXPERIMENTAL

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

Drug: Itraconazole; Drug: sonrotoclax

Interventions

Phenytoin DRUG

Administered orally.

Part A: Phenytoin + Sonrotoclax

Itraconazole DRUG

Administered orally.

Part B: Itraconazole + Sonrotoclax

sonrotoclax DRUG

Administered orally.

Also known as: BGB-11417

Part A: Phenytoin + Sonrotoclax; Part B: Itraconazole + Sonrotoclax

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

Phenytoin; Itraconazole

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles; Piperazines

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: August 19, 2024
• Primary Completion: October 8, 2024
• Study Completion: November 7, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)