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NCT Number: NCT07051993

A Study to Evaluate the Relative Bioavailability of Two Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on ZN-A-1041 Tablet(s) in Healthy Participants

This is a Phase 1, open-label, randomized, two-part study to evaluate the relative bioavailability (rBA) of two tablet formulations compared to the capsule formulation of ZN-A-1041 (Part 1). Part 2 of the study will evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation. No participants were enrolled in Part 2 of the study as it has been cancelled.

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Key information

Conditions

Healthy Participants

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Leeds CRU

Leeds, LS11 9EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) within the range of 18 to 32 kg/m^2, inclusive
  • Negative hepatitis panel and negative HIV antibody screens
  • Negative screening test for latent Mycobacterium tuberculosis infection
  • Able to consume the high-fat meal within the protocol-specified time period and willing to consume 100% of the high-fat meal
  • Able to fast for 8 hours prior to dosing

Exclusion criteria

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder
  • Personal or family history of congenital long QT syndrome
  • History of significant hypersensitivity, intolerance, or allergy to any drug
  • History of acute GI symptoms
  • History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination
  • Have significantly impaired hepatic function
  • Female who is pregnant or breastfeeding or intending to become pregnant during the study or within 90 days following the final ZN-A-1041 administration
  • Have a QTc interval corrected through use of Fredericia's formula >450 millisecond (msec), PR interval >210 msec, QRS complex >120 msec, or heart rate <50 beats per minute (bpm)
  • Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A or CYP2C8
  • Poor peripheral venous access
  • History of malignancy within 5 years prior to enrollment

Treatment and study plan

ZN-A-1041

Drug

Participants will be administered either a ZN-A-1041 capsule or a tablet orally.

Primary outcomes

  1. Maximum Observed Concentration (Cmax)

    Time frame: Days 1-12 (Part 1)

  2. Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t)

    Time frame: Days 1-12 (Part 1)

  3. AUC Extrapolated to Infinity (AUC0-inf)

    Time frame: Days 1-12 (Part 1)

  4. Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax

    Time frame: Days 1-12 (Part 1)

  5. Geometric Mean Ratio and Associated 90% CI of AUC0-t

    Time frame: Days 1-12 (Part 1)

  6. Geometric Mean Ratio and Associated 90% CI of AUC0-inf

    Time frame: Days 1-12 (Part 1)

Secondary outcomes

  1. Time to Maximum Observed Concentration (tmax)

    Time frame: Days 1-12 (Part 1)

  2. Apparent Terminal Elimination Rate Constant

    Time frame: Days 1-12 (Part 1)

  3. Apparent Terminal Elimination Half-Life (t1/2)

    Time frame: Days 1-12 (Part 1)

  4. Apparent Systemic Clearance (CL/F)

    Time frame: Days 1-12 (Part 1)

  5. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)

    Time frame: Days 1-12 (Part 1)

  6. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 16 days

  7. Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline, days 1, 5, 9 and 12 (Part 1)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Randomized, Crossover, Two-Part Study to Evaluate the Relative Bioavailability of Two ZN-A-1041 Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 4, 2025
Registry last updated
Oct 16, 2025

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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