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Completed

NCT Number: NCT06543043

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

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.

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Key information

Conditions

Not Determined

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phenytoin

Drug

Administered orally.

Itraconazole

Drug

Administered orally.

Sonrotoclax

Drug

Administered orally.

Other names: BGB-11417

Primary outcomes

  1. 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

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

    Time frame: Approximately 21 days for Part A and 11 days for Part B

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

    Time frame: Approximately 21 days for Part A and 11 days for Part B

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

    Time frame: Approximately 21 days for Part A and 11 days for Part B

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

    Time frame: Approximately 21 days for Part A and 11 days for Part B

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

    Time frame: Approximately 21 days for Part A and 11 days for Part B

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

    Time frame: Approximately 21 days for Part A and 11 days for Part B

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

    Time frame: Approximately 21 days for Part A and 11 days for Part B

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

    Time frame: 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)

    Time frame: 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

    Number of participants with AEs and SAEs, including findings from vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory assessments.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Collaborators

  • Quotient Sciences

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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