Healthy VolunteersPhase 1NCT07329972
A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Participants
A Phase 1 study testing ZN-A-1041 Formulation 1, ZN-A-1041 Formulation 2 and Rabeprazole in people with Healthy Volunteers, run by Genentech, Inc. at 2 sites in United States.
Trial summary
This study is a phase 1, open-label, randomized, four-period crossover study to evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ZN-A-1041 Formulation 1, ZN-A-1041 Formulation 2 and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2025to 14 Dec 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/m2, inclusive
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs, as determined by the investigator, at Screening and Check-in, as applicable
- Clinical laboratory evaluations (including chemistry panel, CBC, and UA with complete microscopic analysis) within the normal reference ranges for the certified test laboratory at Screening and Check-in
- Negative test for selected drugs of abuse at Screening and Check-in (includes alcohol)
- Negative hepatitis panel (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B surface antibody [unless consistent with vaccination or immunity due to natural infection], and hepatitis C virus antibody) and negative HIV antibody screens
- For women of childbearing potential: agreement to remain abstinent or use contraception
Show all 11Show fewer
- For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm
- Negative screening test for latent Mycobacterium tuberculosis infection
- Able to swallow and retain multiple tablets without chewing or crushing
- 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, gastrointestinal (GI), neurological, or psychiatric disorder, as determined by the investigator
- History or concurrent clinically significant hemorrhagic, bleeding abnormalities, as determined by the investigator
- Personal or family history of congenital long QT syndrome
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- History of GI surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that uncomplicated appendectomy and hernia repair will be allowed
- History of myocardial infarction
Show all 31Show fewer
- History of febrile illness within 10 days prior to the first dose of study drug, or participants with evidence of active systemic infection, as determined by the investigator
- History of acute GI symptoms (e.g., nausea, vomiting, diarrhea, heartburn) as determined by the investigator (or designee) at Screening or Check-in
- History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination as determined by the investigator, optometrist, or ophthalmologist
- Risk for suicidal behavior at Screening as determined by the investigator's clinical assessment and an answer "Yes" to item 4 or 5 within 2 years of Screening, or to suicidal behavior items on the Baseline/Screening version C-SSRS or suicide attempt within 2 years of screening. Non-suicidal self-injurious behavior is not exclusionary.
- Have significantly impaired hepatic function (at Screening or Check-in)
- 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 corrected QT (QTc) interval corrected through use of Fredericia's formula >450 msec for males or >470 for females, PR interval >210 msec, QRS complex >120 msec, or heart rate <50 bpm (at Screening or Check-in)
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically significant, such as symptomatic bradyarrhythmias, bradycardia, or heart block as determined from 12-lead ECG (at Screening, Check-in, or Day 1 predose). Abnormal results can be confirmed by one repeat 12-lead ECG
- History of alcoholism or drug addiction within 1 year prior to Check-in, use of drugs of abuse (including opioids) within 4 weeks of Screening, and/or positive alcohol breath test and/or urinary drug screen at Screening or Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 90 days, whichever is longer, prior to Check-in
- Treatment with intravenous (IV) antibiotics within 8 weeks prior to Screening and/or treatment with oral antibiotics within 4 weeks prior to Screening
- Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A or CYP2C8 within 30 days prior to Check-in
- Use of any other prescription medications/products or vaccines (including seasonal flu, H1N1, and coronavirus 2019 [COVID-19] vaccines) other than oral, implantable, transdermal, and injectable contraceptives or medications administered during the ophthalmic examination within 14 days prior to Check-in, unless deemed acceptable by the investigator
- Use of therapeutic anticoagulation or thrombolytic anticoagulants within 14 days prior to Check-in
- Use of any over-the-counter, non-prescription medications (including vitamins; minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the investigator
- Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to Check-in or a positive cotinine test
- Use of poppy seed-, grapefruit-, star fruit-, pomegranate-, pawpaw-, or Seville orange-containing foods or beverages within 7 days prior to Check-in
- Use of alcohol- or caffeine-containing foods or beverages within 48 hours prior to Check-in, unless deemed acceptable by the investigator
- Participant is not willing to minimize or avoid exposure to natural or artificial sunlight (tanning beds or ultraviolet (UV) A/B treatment) following administration of study drug through 5 days following the final ZN-A-1041 administration
- Participant is not willing to refrain from strenuous exercise from 7 days prior to Check-in and during the period of confinement at the study site (e.g., will not begin a new exercise program or participate in any unusually strenuous physical exertion)
- Poor peripheral venous access as determined by the investigator
- History of malignancy within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix or basal cell skin cancer)
- Donation of blood within 3 months prior to Screening through study completion, donation of plasma within 2 weeks prior to Screening through study completion, or donation of platelets within 6 weeks prior to Screening through study completion
- Receipt of blood products within 2 months prior to Screening and during the entire study duration
- Participants who, in the opinion of the investigator (or designee), should not participate in this clinical study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4989
Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Participants
This study is a phase 1, open-label, randomized, four-period crossover study to evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation in healthy male and female participants.
- Conditions
- Healthy Volunteers
- Being tested
- ZN-A-1041 Formulation 1, ZN-A-1041 Formulation 2, Rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZN-A-1041 Formulation 1Drug
Participants will receive a single dose of ZN-A-1041 Formulation 1 on each specified treatment.
ZN-A-1041 Formulation 2Drug
Participants will receive a single dose of ZN-A-1041 Formulation 2 on each specified treatment.
RabeprazoleDrug
Participants will receive an oral administration of rabeprazole twice daily (BID) on days 9, 10, 15, and 16 and a single dose on Days 11 and 17.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 1; Drug: Rabeprazole |
| Sequence 2 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 1; Drug: Rabeprazole |
| Sequence 3 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 1; Drug: Rabeprazole |
| Sequence 4 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 1; Drug: Rabeprazole |
| Sequence 5 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 2; Drug: Rabeprazole |
| Sequence 6 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 2; Drug: Rabeprazole |
| Sequence 7 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 2; Drug: Rabeprazole |
| Sequence 8 | Experimental | Not described Receives: Drug: ZN-A-1041 Formulation 2; Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax)
Measured: Days 1 to 8, 11 to 14, and 17 to 20
Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t)
Measured: Days 1 to 8, 11 to 14, and 17 to 20
AUC Extrapolated to Infinity (AUC0-∞)
Measured: Days 1 to 8, 11 to 14, and 17 to 20
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞
Measured: Days 1 to 8, 11 to 14, and 17 to 20
Secondary outcomes (18)
ZN-A-1041 PK Parameters Time to Maximum Observed Concentration (Tmax) for All Treatments
Measured: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Rate Constant (λz) for All Treatments
Measured: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Half-life (t1/2) for All Treatments
Measured: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Systemic Clearance (CL/F) for All Treatments
Measured: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for All Treatments
Measured: Days 1 to 8, 11 to 14, and 17 to 20
Incidence of Adverse Events (AEs), Including Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Measured: Up to approximately 8.5 weeks
Severity of AEs, Including SAEs and AESIs
Measured: Up to approximately 8.5 weeks
Number of Participants with Abnormalities in Clinical Laboratory Results
Measured: Baseline, Days 2, 4, 6, 10, 16, and 20
Changes from Baseline in Oral Temperature Measurements
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Columbia Suicide Severity Rating Scale (C-SSRS) Questionnaires
Measured: Baseline, Day 1, 5, 11, 17, and 20
Changes from Baseline in Respiratory Rate Measurements
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Systolic Blood Pressure Measurements
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Pulse Rate Measurements
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Diastolic Blood Pressure Measurements
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead Electrocardiogram (ECG) Parameters (RR, PR, QRS, and QT Duration)
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (Heart Rate)
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (Sinus Rhythm)
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (QTcF)
Measured: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start21 Nov 2025
- Primary completion14 Dec 2025
- Study completion14 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329972
- Sponsor's protocol ID
- GP46367
- Status last verified
- May 2026
- First submitted
- 20 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Participants
- ClinicalTrials.gov ID
- NCT07329972
- Acronym / sponsor ID
- GP46367
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 14 Dec 2025 (actual)
- Study completion
- 14 Dec 2025 (actual)
- First posted
- 9 Jan 2026 (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 study is a phase 1, open-label, randomized, four-period crossover study to evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation in healthy male and female participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: ZN-A-1041 Formulation 1, Drug: Rabeprazole |
| Sequence 2 | Experimental | Drug: ZN-A-1041 Formulation 1, Drug: Rabeprazole |
| Sequence 3 | Experimental | Drug: ZN-A-1041 Formulation 1, Drug: Rabeprazole |
| Sequence 4 | Experimental | Drug: ZN-A-1041 Formulation 1, Drug: Rabeprazole |
| Sequence 5 | Experimental | Drug: ZN-A-1041 Formulation 2, Drug: Rabeprazole |
| Sequence 6 | Experimental | Drug: ZN-A-1041 Formulation 2, Drug: Rabeprazole |
| Sequence 7 | Experimental | Drug: ZN-A-1041 Formulation 2, Drug: Rabeprazole |
| Sequence 8 | Experimental | Drug: ZN-A-1041 Formulation 2, Drug: Rabeprazole |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Body mass index (BMI) within the range of 18 to 32 kg/m2, inclusive
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs, as determined by the investigator, at Screening and Check-in, as applicable
- Clinical laboratory evaluations (including chemistry panel, CBC, and UA with complete microscopic analysis) within the normal reference ranges for the certified test laboratory at Screening and Check-in
- Negative test for selected drugs of abuse at Screening and Check-in (includes alcohol)
- Negative hepatitis panel (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B surface antibody [unless consistent with vaccination or immunity due to natural infection], and hepatitis C virus antibody) and negative HIV antibody screens
Key exclusion criteria (31 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder, as determined by the investigator
- History or concurrent clinically significant hemorrhagic, bleeding abnormalities, as determined by the investigator
- Personal or family history of congenital long QT syndrome
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- History of GI surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that uncomplicated appendectomy and hernia repair will be allowed
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-1041 Formulation 1Participants will receive a single dose of ZN-A-1041 Formulation 1 on each specified treatment. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| ZN-A-1041 Formulation 2Participants will receive a single dose of ZN-A-1041 Formulation 2 on each specified treatment. | Drug | Sequence 5, Sequence 6, Sequence 7, Sequence 8 |
| RabeprazoleParticipants will receive an oral administration of rabeprazole twice daily (BID) on days 9, 10, 15, and 16 and a single dose on Days 11 and 17. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8 |
Primary outcome
Maximum Observed Concentration (Cmax)
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
AUC Extrapolated to Infinity (AUC0-∞)
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
18 secondary outcomes
ZN-A-1041 PK Parameters Time to Maximum Observed Concentration (Tmax) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Rate Constant (λz) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Half-life (t1/2) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Systemic Clearance (CL/F) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
Incidence of Adverse Events (AEs), Including Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Time frame: Up to approximately 8.5 weeks
Severity of AEs, Including SAEs and AESIs
Time frame: Up to approximately 8.5 weeks
Number of Participants with Abnormalities in Clinical Laboratory Results
Time frame: Baseline, Days 2, 4, 6, 10, 16, and 20
Changes from Baseline in Oral Temperature Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Columbia Suicide Severity Rating Scale (C-SSRS) Questionnaires
Time frame: Baseline, Day 1, 5, 11, 17, and 20
Changes from Baseline in Respiratory Rate Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Systolic Blood Pressure Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Pulse Rate Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Diastolic Blood Pressure Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead Electrocardiogram (ECG) Parameters (RR, PR, QRS, and QT Duration)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (Heart Rate)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (Sinus Rhythm)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (QTcF)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
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 11 May 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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
Hoffmann-La Roche
2 sites 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 Formulation 1, ZN-A-1041 Formulation 2 and Rabeprazole in people with Healthy Volunteers, run by Genentech, Inc. at 2 sites in United States.
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 11 inclusion and 31 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 to 8, 11 to 14, and 17 to 20). The study lists 4 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 11 May 2026.