Overweight and/or ObesityPhase 1NCT04616339
STUDY TO COMPARE PHARMACOKINETICS (PK) OF SINGLE ORAL DOSES OF DIFFERENT PF-06882961 FORMULATIONS IN PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY
A Phase 1 study testing PF-06882961 100 mg in people with Overweight and/or Obesity, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and/or Obesity
- What is being tested?
- PF-06882961 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Nov 2020to 19 Jul 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vitals and ECGs. Participants with obesity that are otherwise healthy may be enrolled in this study.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- A total body weight >50 kg (110 lb) and BMI of 25.0 to 40.0 kg/m2 at the screening visit.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HBsAg, HBsAb, HBcAb, HCVAb or HIV. Hepatitis B vaccination is allowed.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 halflives (whichever is longer) prior to the first dose of study intervention.
Show all 19Show fewer
- Use of hormone replacement therapy or oral/injectable contraceptives.
- Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF 06882961.
- A positive urine drug test.
- Using a properly sized and calibrated BP cuff, screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.25 × upper limit of normal (ULN);
- Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
- HbA1c ≥6.5%;
- Fasting blood glucose ≥126 mg/dL (7 mmol/L);
- Calcitonin > ULN;
- eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A 2-PART, PHASE 1, OPEN LABEL STUDY WITH A 4-PERIOD, 4-SEQUENCE, CROSSOVER DESIGN IN COHORT 1 AND A 2-PERIOD, 2-SEQUENCE CROSSOVER DESIGN IN COHORT 2 TO COMPARE THE SINGLE DOSE PHARMACOKINETICS OF FIVE DIFFERENT FORMULATIONS OF PF-06882961 ADMINISTERED ORALLY TO OTHERWISE HEALTHY ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY
The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961.
- Conditions
- Overweight and/or Obesity
- Being tested
- PF-06882961 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06882961 100 mgDrug
PF-06882961 100 mg will be provided in 5 different oral formulations A, B, C, D, and E. Cohort 1 is a randomized, open-label, single dose, 4-period, 4-sequence, crossover design where the first 2 periods are cross-over (Formulations A and B) and the second 2 periods are crossover (Formulations C and D).
Cohort 2 is a randomized, open-label, single dose, 2-period, 2 sequence, crossover design (Formulations A and E)
| Study group | Role | What they receive |
|---|---|---|
| Formulation A (Cohort 1) | Active comparator | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation A at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed Receives: Drug: PF-06882961 100 mg |
| Formulation B (Cohort 1) | Experimental | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation B at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed Receives: Drug: PF-06882961 100 mg |
| Formulation C (Cohort 1) | Experimental | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation C at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed Receives: Drug: PF-06882961 100 mg |
| Formulation D (Cohort 1) | Experimental | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation D at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed Receives: Drug: PF-06882961 100 mg |
| Formulation A (Cohort 2) | Active comparator | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation A at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed Receives: Drug: PF-06882961 100 mg |
| Formulation E (Cohort 2) | Experimental | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation E at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed Receives: Drug: PF-06882961 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B cohort 1
Measured: Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and B cohort 1
Measured: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations A and B cohort 1
Measured: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and E cohort 2
Measured: Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and E cohort 2
Measured: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations A and E cohort 2
Measured: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Secondary outcomes (7)
Number of Subjects Reporting Treatment-emergent adverse events (AEs)
Measured: Baseline through End of Study(Day 28)
Number of Participants With Clinical Laboratory Abnormalities
Measured: Baseline, Day 1 and Day 3
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: Baseline, Day 1 and Day 3
Number of Participants With Abnormal Electrocardiogram (ECG)
Measured: Baseline, Day 1 and Day 3
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations C and D
Measured: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations C and D
Measured: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations C and D
Measured: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start4 Nov 2020
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616339
- Sponsor's protocol ID
- C3421010
- Other IDs
- 2020-001016-24
- Status last verified
- Mar 2022
- First submitted
- 30 Oct 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-PART, PHASE 1, OPEN LABEL STUDY WITH A 4-PERIOD, 4-SEQUENCE, CROSSOVER DESIGN IN COHORT 1 AND A 2-PERIOD, 2-SEQUENCE CROSSOVER DESIGN IN COHORT 2 TO COMPARE THE SINGLE DOSE PHARMACOKINETICS OF FIVE DIFFERENT FORMULATIONS OF PF-06882961 ADMINISTERED ORALLY TO OTHERWISE HEALTHY ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY
- ClinicalTrials.gov ID
- NCT04616339
- Acronym / sponsor ID
- C3421010
- Conditions
- Overweight and/or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 4 Nov 2020 (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.
The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Formulation A (Cohort 1) | Active comparator | Drug: PF-06882961 100 mgFollowing an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation A at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation B (Cohort 1) | Experimental | Drug: PF-06882961 100 mgFollowing an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation B at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation C (Cohort 1) | Experimental | Drug: PF-06882961 100 mgFollowing an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation C at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation D (Cohort 1) | Experimental | Drug: PF-06882961 100 mgFollowing an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation D at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation A (Cohort 2) | Active comparator | Drug: PF-06882961 100 mgFollowing an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation A at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation E (Cohort 2) | Experimental | Drug: PF-06882961 100 mgFollowing an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation E at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vitals and ECGs. Participants with obesity that are otherwise healthy may be enrolled in this study.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- A total body weight >50 kg (110 lb) and BMI of 25.0 to 40.0 kg/m2 at the screening visit.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol.
Key exclusion criteria (19 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HBsAg, HBsAb, HBcAb, HCVAb or HIV. Hepatitis B vaccination is allowed.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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 |
|---|---|---|
| PF-06882961 100 mgPF-06882961 100 mg will be provided in 5 different oral formulations A, B, C, D, and E. Cohort 1 is a randomized, open-label, single dose, 4-period, 4-sequence, crossover design where the first 2 periods are cross-over (Formulations A and B) and the second 2 periods are crossover (Formulations C and D). Cohort 2 is a randomized, open-label, single dose, 2-period, 2 sequence, crossover design (Formulations A and E) | Drug | Formulation A (Cohort 1), Formulation A (Cohort 2), Formulation B (Cohort 1), Formulation C (Cohort 1), Formulation D (Cohort 1), Formulation E (Cohort 2) |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B cohort 1
Time frame: Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and B cohort 1
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations A and B cohort 1
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and E cohort 2
Time frame: Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and E cohort 2
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations A and E cohort 2
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
7 secondary outcomes
Number of Subjects Reporting Treatment-emergent adverse events (AEs)
Time frame: Baseline through End of Study(Day 28)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline, Day 1 and Day 3
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline, Day 1 and Day 3
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: Baseline, Day 1 and Day 3
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations C and D
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations C and D
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations C and D
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
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 4 Apr 2022.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 PF-06882961 100 mg in people with Overweight and/or Obesity, run by Pfizer at 1 site in Belgium.
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 19 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 4 Apr 2022. 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 Belgium. 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?
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B cohort 1 (time frame: Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)). 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 4 Apr 2022.