Healthy ParticipantsPhase 1NCT07051993
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
A Phase 1 study testing ZN-A-1041 in people with Healthy Participants, run by Genentech, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- ZN-A-1041
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2025to 12 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Healthy Participants
- Being tested
- ZN-A-1041
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZN-A-1041Drug
Participants will be administered either a ZN-A-1041 capsule or a tablet orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ZN-A-1041 | Experimental | Participants will be administered a single dose of ZN-A-1041 orally. Receives: Drug: ZN-A-1041 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax)
Measured: Days 1-12 (Part 1)
Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t)
Measured: Days 1-12 (Part 1)
AUC Extrapolated to Infinity (AUC0-inf)
Measured: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax
Measured: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-t
Measured: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-inf
Measured: Days 1-12 (Part 1)
Secondary outcomes (7)
Time to Maximum Observed Concentration (tmax)
Measured: Days 1-12 (Part 1)
Apparent Terminal Elimination Rate Constant
Measured: Days 1-12 (Part 1)
Apparent Terminal Elimination Half-Life (t1/2)
Measured: Days 1-12 (Part 1)
Apparent Systemic Clearance (CL/F)
Measured: Days 1-12 (Part 1)
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Measured: Days 1-12 (Part 1)
Percentage of Participants With Adverse Events (AEs)
Measured: Up to approximately 16 days
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline, days 1, 5, 9 and 12 (Part 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start27 Jun 2025
- Primary completion12 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051993
- Sponsor's protocol ID
- GP45607
- Status last verified
- Oct 2025
- First submitted
- 26 Jun 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07051993
- Acronym / sponsor ID
- GP45607
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1: ZN-A-1041 | Experimental | Drug: ZN-A-1041Participants will be administered a single dose of ZN-A-1041 orally. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZN-A-1041Participants will be administered either a ZN-A-1041 capsule or a tablet orally. | Drug | Part 1: ZN-A-1041 |
Primary outcome
Maximum Observed Concentration (Cmax)
Time frame: Days 1-12 (Part 1)
Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Days 1-12 (Part 1)
AUC Extrapolated to Infinity (AUC0-inf)
Time frame: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax
Time frame: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-t
Time frame: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-inf
Time frame: Days 1-12 (Part 1)
7 secondary outcomes
Time to Maximum Observed Concentration (tmax)
Time frame: Days 1-12 (Part 1)
Apparent Terminal Elimination Rate Constant
Time frame: Days 1-12 (Part 1)
Apparent Terminal Elimination Half-Life (t1/2)
Time frame: Days 1-12 (Part 1)
Apparent Systemic Clearance (CL/F)
Time frame: Days 1-12 (Part 1)
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Time frame: Days 1-12 (Part 1)
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 16 days
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZN-A-1041 in people with Healthy Participants, run by Genentech, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Concentration (Cmax) (time frame: Days 1-12 (Part 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.