Healthy Participants
Conditions
Brief summary
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.
Interventions
DRUGZN-A-1041
Participants will be administered either a ZN-A-1041 capsule or a tablet orally.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax | Days 1-12 (Part 1) |
| Geometric Mean Ratio and Associated 90% CI of AUC0-t | Days 1-12 (Part 1) |
| Geometric Mean Ratio and Associated 90% CI of AUC0-inf | Days 1-12 (Part 1) |
| Maximum Observed Concentration (Cmax) | Days 1-12 (Part 1) |
| Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t) | Days 1-12 (Part 1) |
| AUC Extrapolated to Infinity (AUC0-inf) | Days 1-12 (Part 1) |
Secondary
| Measure | Time frame |
|---|---|
| Time to Maximum Observed Concentration (tmax) | Days 1-12 (Part 1) |
| Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, days 1, 5, 9 and 12 (Part 1) |
| Apparent Terminal Elimination Rate Constant | Days 1-12 (Part 1) |
| Apparent Terminal Elimination Half-Life (t1/2) | Days 1-12 (Part 1) |
| Apparent Systemic Clearance (CL/F) | Days 1-12 (Part 1) |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) | Days 1-12 (Part 1) |
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 16 days |
Countries
United Kingdom
Outcome results
None listed