Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06153758
• Collaborator: (none)
• Enrollment: 20
• Arms: 4
• Anticipated Duration (Months): 2.1

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Nov 27, 2023
• Anticipated Primary Completion Date: Jan 29, 2024
• Anticipated Study Completion Date: Jan 29, 2024

Arms and Interventions

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 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)

Outcome Measures

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 [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 [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 [Baseline to Day 35]

   Safety Parameters

2. Number of Participants with Treatment-Emergent Adverse Events [Baseline to Day 35]

   Safety Parameters

3. Number of Participants with Clinically Significant ECG Abnormalities [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 [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 [Baseline to Day 35]

   Blood hematology and Chemistry and Urinalysis

6. Number of Participants with Serious Adverse Events [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT06153758
• Other Study ID Numbers: C3421074
• First Posted: Dec 1, 2023
• Last Update Posted: Dec 1, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 1, 2023