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

An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Sonrotoclax (BGB-11417) in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Not Determined
• Intervention / Treatment: Drug: Itraconazole; Drug: Phenytoin; Drug: sonrotoclax

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Phenytoin + Sonrotoclax; Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.	Drug: Phenytoin; Administered orally.; Drug: sonrotoclax; Administered orally.; Other Names: BGB-11417
Experimental: Part B: Itraconazole + Sonrotoclax; Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants.	Drug: Itraconazole; Administered orally.; Drug: sonrotoclax; Administered orally.; Other Names: BGB-11417

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts A and B: Number of Participants with Adverse Events (AEs)	Number of participants with AEs and SAEs, including findings from vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory assessments.	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

Collaborators and Investigators

• Sponsor: BeiGene
• Collaborators: Quotient Sciences
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): November 7, 2024

Study Registration Dates

• First Submitted: August 3, 2024
• First Submitted That Met QC Criteria: August 3, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: healthy volunteers; phenytoin; itraconazole; BGB-11417; sonrotoclax
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Anticonvulsants; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inducers; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP1A2 Inducers; Itraconazole; Phenytoin
• Other Study ID Numbers: BGB-11417-107; QSC302214 (Other Identifier: Quotient Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No