Healthy ParticipantsPhase 1NCT06153758
Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults
A Phase 1 study testing Danuglipron in people with Healthy Participants and Healthy Subjects, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Healthy Subjects
- What is being tested?
- Danuglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 30 Sep 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older and overtly healthy
- Body mass Index (BMI) between 16-32 kg/m2; and a total body weight >50 kg (110 lb)
Who cannot join
- Evidence or history of clinically significant medical conditions or laboratory abnormality
- Any condition possibly affecting drug absorption
- Known intolerance/hypersensitivity to a GLP-1 R agonist
- Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: A Phase 1, 4-Part, Open-Label, Randomized Study With A 5-Period, 4 Sequence, Crossover Design to Compare the Single Dose Pharmacokinetics Between Immediate and Modified Release Formulations of Danuglipron Administered Orally to Healthy Adult Participants
The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.
- Conditions
- Healthy Participants, Healthy Subjects
- Being tested
- Danuglipron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanuglipronDrug
Also called PF-06882961
Danuglipron oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period Receives: Drug: Danuglipron |
| Part B | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period Receives: Drug: Danuglipron |
| Part C | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period Receives: Drug: Danuglipron |
| Part D | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period Receives: Drug: Danuglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state
Measured: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state
Measured: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state
Measured: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state
Measured: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state
Measured: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state
Measured: Predose to 48 hours post danuglipron administration
Secondary outcomes (7)
All Parts: Number of Participants reporting Treatment Emergent Adverse Events
Measured: From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities
Measured: From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities
Measured: From baseline up to 28-35 days post last dose taken
All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities
Measured: From baseline up to 28-35 days post last dose taken
All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state
Measured: Predose to 48 hours post danuglipron administration
All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state
Measured: Predose to 48 hours post danuglipron administration
All Parts: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fed state
Measured: Predose to 48 hours post danuglipron administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start27 Nov 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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 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
- Model description
- 4-Part
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT06153758
- Sponsor's protocol ID
- C3421074
- Status last verified
- Oct 2024
- First submitted
- 22 Nov 2023
- Last updated
- 21 Oct 2024
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 4-Part, Open-Label, Randomized Study With A 5-Period, 4 Sequence, Crossover Design to Compare the Single Dose Pharmacokinetics Between Immediate and Modified Release Formulations of Danuglipron Administered Orally to Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06153758
- Acronym / sponsor ID
- C3421074
- Conditions
- Healthy Participants, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Dec 2023 (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 learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4-Part
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: DanuglipronParticipants will receive a single oral dose of danuglipron on Day 1 of each period |
| Part B | Experimental | Drug: DanuglipronParticipants will receive a single oral dose of danuglipron on Day 1 of each period |
| Part C | Experimental | Drug: DanuglipronParticipants will receive a single oral dose of danuglipron on Day 1 of each period |
| Part D | Experimental | Drug: DanuglipronParticipants will receive a single oral dose of danuglipron on Day 1 of each period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older and overtly healthy
- Body mass Index (BMI) between 16-32 kg/m2; and a total body weight >50 kg (110 lb)
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant medical conditions or laboratory abnormality
- Any condition possibly affecting drug absorption
- Known intolerance/hypersensitivity to a GLP-1 R agonist
- Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of 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 |
|---|---|---|
| DanuglipronAlso: PF-06882961Danuglipron oral tablets | Drug | Part A, Part B, Part C, Part D |
Primary outcome
Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state
Time frame: Predose to 48 hours post danuglipron administration
7 secondary outcomes
All Parts: Number of Participants reporting Treatment Emergent Adverse Events
Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state
Time frame: Predose to 48 hours post danuglipron administration
All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state
Time frame: Predose to 48 hours post danuglipron administration
All Parts: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fed state
Time frame: Predose to 48 hours post danuglipron administration
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 21 Oct 2024.
- 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 Danuglipron in people with Healthy Participants and Healthy Subjects, run by Pfizer at 1 site 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 2 inclusion and 4 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 21 Oct 2024. 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 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?
Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state (time frame: Predose to 48 hours post danuglipron administration). 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 21 Oct 2024.