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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants, Healthy Subjects

Intervention / Treatment
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* Drug: Formulation A
* Drug: Formulation B
* Drug: Formulation C
* Drug: Formulation D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>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<br>* Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet<br>Drug: Formulation B<br>* Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation C<br>* Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation D<br>* Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)<br>|
| Experimental: Sequence 2<br>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<br>* Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet<br>Drug: Formulation B<br>* Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation C<br>* Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation D<br>* Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)<br>|
| Experimental: Sequence 3<br>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<br>* Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet<br>Drug: Formulation B<br>* Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation C<br>* Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation D<br>* Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)<br>|
| Experimental: Sequence 4<br>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<br>* Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet<br>Drug: Formulation B<br>* Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation C<br>* Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)<br>Drug: Formulation D<br>* Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Curve from Time Zero to Extrapolated infinite Time (AUCinf) for Formulations A, B, C and D, in a fasted state | Plasma PF-06882961 PK parameters | 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 | 
| Maximum observed plasma concentration for Formulations A, B, C and D, in a fasted state | Plasma PF-06882961 PK parameters | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Non-Serious Adverse Events | Safety Parameters | Baseline to Day 35 | 
| Number of Participants with Treatment-Emergent Adverse Events | Safety Parameters | Baseline to Day 35 | 
| Number of Participants with Clinically Significant ECG Abnormalities | ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate | Baseline to Day 35 | 
| Number of Participants with Clinically Significant Vital Sign Abnormalities | Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate | Baseline to Day 35 | 
| Number of Participants with Clinically Significant Abnormal Laboratory Values | Blood hematology and Chemistry and Urinalysis | Baseline to Day 35 | 
| Number of Participants with Serious Adverse Events | Safety Parameters | Baseline to Day 35 | 
| 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 | Plasma PF-06882961 PK parameters | 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 | 
| Maximum observed plasma concentration for MR formulation B in the fed (Test), compared to the fasted state | Plasma PF-06882961 PK parameters | 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 |