Healthy ParticipantsPhase 1NCT07723833
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
A Phase 1 study testing Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A and Elecoglipron Reference Formulation Dose B in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial summary
The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A and Elecoglipron Reference Formulation Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jul 2026to 18 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
- Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.
Who cannot join
- History of any clinically important disease or disorder.
- History of acute pancreatitis.
- History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Participants who have previously received elecoglipron within the last 3 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States2 sites, 2 recruiting
- Recruiting
Research Site
Brooklyn, Maryland, 21225
- Recruiting
Research Site
Glendale, California, 91206
About this study
Official title: A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.
Read the detailed description
This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).
In total 3 formulations will be evaluated at 2 dose levels each:
- Reference formulation
- Test formulation 1
- Test formulation 2
The study will comprise:
- A Screening Period.
- 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period.
- A final Follow-up Visit.
- Conditions
- Healthy Participants
- Being tested
- Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A, Elecoglipron Reference Formulation Dose B, Elecoglipron Test formulation 1 Dose B, Elecoglipron Test formulation 2 Dose A
- Keywords
- Glucagon-like peptide receptor agonist (GLP-1RA), Type 2 Diabetes Mellitus (T2DM), Glucose Metabolism Disorders, Metabolic Diseases, Obesity management, Pharmacokinetics, Relative bioavailability, Obesity and Related Co-morbidities
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elecoglipron Reference Formulation Dose ADrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose ADrug
Elecoglipron tablets will be administered orally.
Elecoglipron Reference Formulation Dose BDrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose BDrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose ADrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose BDrug
Elecoglipron tablets will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-Treatment Sequence A | Experimental | Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: Elecoglipron Test formulation 1 Dose A |
| Cohort 1 - Treatment Sequence B | Experimental | Participant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: Elecoglipron Test formulation 1 Dose A |
| Cohort 2 - Treatment Sequence C | Experimental | Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: Elecoglipron Test formulation 1 Dose B |
| Cohort 2 - Treatment Sequence D | Experimental | Participant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: Elecoglipron Test formulation 1 Dose B |
| Cohort 3 - Treatment Sequence E | Experimental | Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: Elecoglipron Test formulation 2 Dose A |
| Cohort 3 - Treatment Sequence F | Experimental | Participant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: Elecoglipron Test formulation 2 Dose A |
| Cohort 4 - Treatment Sequence G | Experimental | Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: Elecoglipron Test formulation 2 Dose B |
| Cohort 4 - Treatment Sequence H | Experimental | Participant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: Elecoglipron Test formulation 2 Dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed drug concentration (Cmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Area under concentration-time curve from time 0 to infinity (AUCinf)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Time to reach maximum observed concentration (tmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Terminal elimination rate constant (λz)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Terminal elimination half-life (t1/2λz)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Apparent total body clearance (CL/F)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Apparent volume of distribution based on the terminal phase (Vz/F)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: At pre-defined intervals from Day 1 to Day 15
Secondary outcomes (1)
Number of participants with adverse events (AEs)
To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start27 Jul 2026
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 2026 (estimated)
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 AstraZenecaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723833
- Sponsor's protocol ID
- D7260C00023
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
- ClinicalTrials.gov ID
- NCT07723833
- Acronym / sponsor ID
- D7260C00023
- Conditions
- Healthy Participants
- Keywords
- Glucagon-like peptide receptor agonist (GLP-1RA), Type 2 Diabetes Mellitus (T2DM), Glucose Metabolism Disorders, Metabolic Diseases, Obesity management, Pharmacokinetics, Relative bioavailability, Obesity and Related Co-morbidities
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 23 Jul 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.
The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.
Detailed description
This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).
In total 3 formulations will be evaluated at 2 dose levels each:
- Reference formulation
- Test formulation 1
- Test formulation 2
The study will comprise:
- A Screening Period.
- 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period.
- A final Follow-up Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-Treatment Sequence A | Experimental | Drug: Elecoglipron Reference Formulation Dose A, Drug: Elecoglipron Test formulation 1 Dose AParticipant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2. |
| Cohort 1 - Treatment Sequence B | Experimental | Drug: Elecoglipron Reference Formulation Dose A, Drug: Elecoglipron Test formulation 1 Dose AParticipant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2. |
| Cohort 2 - Treatment Sequence C | Experimental | Drug: Elecoglipron Reference Formulation Dose B, Drug: Elecoglipron Test formulation 1 Dose BParticipant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2. |
| Cohort 2 - Treatment Sequence D | Experimental | Drug: Elecoglipron Reference Formulation Dose B, Drug: Elecoglipron Test formulation 1 Dose BParticipant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2. |
| Cohort 3 - Treatment Sequence E | Experimental | Drug: Elecoglipron Reference Formulation Dose A, Drug: Elecoglipron Test formulation 2 Dose AParticipant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2. |
| Cohort 3 - Treatment Sequence F | Experimental | Drug: Elecoglipron Reference Formulation Dose A, Drug: Elecoglipron Test formulation 2 Dose AParticipant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2. |
| Cohort 4 - Treatment Sequence G | Experimental | Drug: Elecoglipron Reference Formulation Dose B, Drug: Elecoglipron Test formulation 2 Dose BParticipant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2. |
| Cohort 4 - Treatment Sequence H | Experimental | Drug: Elecoglipron Reference Formulation Dose B, Drug: Elecoglipron Test formulation 2 Dose BParticipant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
Key exclusion criteria (6 listed)
- History of any clinically important disease or disorder.
- History of acute pancreatitis.
- History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
- Any clinically important illness, medical/surgical procedure, or trauma.
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 |
|---|---|---|
| Elecoglipron Reference Formulation Dose AElecoglipron tablets will be administered orally. | Drug | Cohort 1 - Treatment Sequence B, Cohort 1-Treatment Sequence A, Cohort 3 - Treatment Sequence E, Cohort 3 - Treatment Sequence F |
| Elecoglipron Test formulation 1 Dose AElecoglipron tablets will be administered orally. | Drug | Cohort 1 - Treatment Sequence B, Cohort 1-Treatment Sequence A |
| Elecoglipron Reference Formulation Dose BElecoglipron tablets will be administered orally. | Drug | Cohort 2 - Treatment Sequence C, Cohort 2 - Treatment Sequence D, Cohort 4 - Treatment Sequence G, Cohort 4 - Treatment Sequence H |
| Elecoglipron Test formulation 1 Dose BElecoglipron tablets will be administered orally. | Drug | Cohort 2 - Treatment Sequence C, Cohort 2 - Treatment Sequence D |
| Elecoglipron Test formulation 2 Dose AElecoglipron tablets will be administered orally. | Drug | Cohort 3 - Treatment Sequence E, Cohort 3 - Treatment Sequence F |
| Elecoglipron Test formulation 2 Dose BElecoglipron tablets will be administered orally. | Drug | Cohort 4 - Treatment Sequence G, Cohort 4 - Treatment Sequence H |
Primary outcome
Maximum observed drug concentration (Cmax)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time to reach maximum observed concentration (tmax)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Terminal elimination rate constant (λz)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Terminal elimination half-life (t1/2λz)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Apparent total body clearance (CL/F)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)
Time frame: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
1 secondary outcome
Number of participants with adverse events (AEs)
Time frame: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
AstraZeneca Clinical Study Information Center contact
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 Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A and Elecoglipron Reference Formulation Dose B in people with Healthy Participants, run by AstraZeneca 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed drug concentration (Cmax) (time frame: At pre-defined intervals from Day 1 to Day 15). The study lists 11 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 Sep 2026.