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Trial record 1 of 2 for:    danuglipron
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Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults

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ClinicalTrials.gov Identifier: NCT06153758
Recruitment Status : Recruiting
First Posted : December 1, 2023
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Participants Healthy Subjects Drug: Formulation A Drug: Formulation B Drug: Formulation C Drug: Formulation D Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, 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
Actual Study Start Date : November 27, 2023
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence 1
Period 1: 80 mg dose of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 2: 80 mg dose of danuglipron MR, fasted state(Formulation B, 1×80 mg tablet) Period 3: 80 mg dose of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 4: 80 mg of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet) Period 5: 80 mg dose of danuglipron MR, fed conditions (Formulation B, 1×80 mg tablet)
 Drug: Formulation A
Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet

Drug: Formulation B
Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)

Drug: Formulation C
Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)

Drug: Formulation D
Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)
Experimental: Sequence 2
Period 1: 80 mg dose of danuglipron MR, fasted state (Formulation B, 1×80 mg tablet), Period 2: 80 mg tablet of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet), Period 3: 80 mg tablet of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 4: 80 mg tablet of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 5: 80 mg dose of danuglipron MR, fed condition (Formulation B, 1×80 mg tablet)
 Drug: Formulation A
Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet

Drug: Formulation B
Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)

Drug: Formulation C
Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)

Drug: Formulation D
Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)
Experimental: Sequence 3
Period 1: 80 mg dose of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 2: 80 mg dose of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 3: 80 mg dose of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet) Period 4: 80 mg dose of danuglipron MR, fasted state (Formulation B, 1×80 mg tablet) Period 5: 80 mg dose of danuglipron MR, fed condition (Formulation B, 1×80 mg tablet)
 Drug: Formulation A
Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet

Drug: Formulation B
Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)

Drug: Formulation C
Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)

Drug: Formulation D
Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)
Experimental: Sequence 4
Period 1: 80 mg dose of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet), Period 2: 80 mg dose of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 3:80 mg dose of danuglipron MR, fasted state (Formulation B, 1×80 mg tablet) Period 4: 80 mg dose of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 5: 80 mg dose of danuglipron MR, fed consition (Formulation B, 1×80 mg tablet)
 Drug: Formulation A
Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet

Drug: Formulation B
Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)

Drug: Formulation C
Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)

Drug: Formulation D
Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Curve from Time Zero to Extrapolated infinite Time (AUCinf) for Formulations A, B, C and D, in a fasted state [ Time Frame: Day 1 hour (hr) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and hr 36 and Day 3 hr 48 ]
    Plasma PF-06882961 PK parameters

  2. Maximum observed plasma concentration for Formulations A, B, C and D, in a fasted state [ Time Frame: Day 1 hour (hr) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and hr 36 and Day 3 hr 48 ]
    Plasma PF-06882961 PK parameters


Secondary Outcome Measures :
  1. Number of Participants with Non-Serious Adverse Events [ Time Frame: Baseline to Day 35 ]
    Safety Parameters

  2. Number of Participants with Treatment-Emergent Adverse Events [ Time Frame: Baseline to Day 35 ]
    Safety Parameters

  3. Number of Participants with Clinically Significant ECG Abnormalities [ Time Frame: Baseline to Day 35 ]
    ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate

  4. Number of Participants with Clinically Significant Vital Sign Abnormalities [ Time Frame: Baseline to Day 35 ]
    Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate

  5. Number of Participants with Clinically Significant Abnormal Laboratory Values [ Time Frame: Baseline to Day 35 ]
    Blood hematology and Chemistry and Urinalysis

  6. Number of Participants with Serious Adverse Events [ Time Frame: Baseline to Day 35 ]
    Safety Parameters

  7. Area Under the Plasma Curve from Time Zero to Extrapolated infinite Time (AUCinf) for MR formulation B in the fed (Test), compared to the fasted state [ Time Frame: Day 1 hour (hr) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and hr 36 and Day 3 hr 48 ]
    Plasma PF-06882961 PK parameters

  8. Maximum observed plasma concentration for MR formulation B in the fed (Test), compared to the fasted state [ Time Frame: Day 1 hour (hr) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and hr 36 and Day 3 hr 48 ]
    Plasma PF-06882961 PK parameters


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older and overtly healthy
  • BMI16-32 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant medical conditions, any condition possibly affecting drug absorption, any medical or psychiatric conditions
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06153758


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Anaheim Clinical Trials, LLC Recruiting
Anaheim, California, United States, 92801
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT06153758    
Other Study ID Numbers: C3421074
First Posted: December 1, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No