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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153758
• Other study ID #: C3421074
• Status: Recruiting
• Phase: Phase 1
• Start date: November 27, 2023
• Est. completion date: July 22, 2024

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 22, 2024
• Est. primary completion date: July 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants
• Healthy Subjects

Intervention

Drug:
• Formulation A
Danuglipron IR PF-06882961-82 40 mg Oval White to Off-White Tablet
• Formulation B
Danuglipron MR, Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Long Release)
• Formulation C
Danuglipron MR, Danuglipron 80 mgA (1000 mgW) Oval MR Tablet (Long Release)
• Formulation D
Danuglipron MR Danuglipron 80 mgA (500 mgW) Oval MR Tablet (Short Release)

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants with Non-Serious Adverse Events	Safety Parameters	Baseline to Day 35
Secondary	Number of Participants with Treatment-Emergent Adverse Events	Safety Parameters	Baseline to Day 35
Secondary	Number of Participants with Clinically Significant ECG Abnormalities	ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate	Baseline to Day 35
Secondary	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
Secondary	Number of Participants with Clinically Significant Abnormal Laboratory Values	Blood hematology and Chemistry and Urinalysis	Baseline to Day 35
Secondary	Number of Participants with Serious Adverse Events	Safety Parameters	Baseline to Day 35
Secondary	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
Secondary	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

External Links

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