NCT05807490

A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-07328948 IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study has two parts: Part A and Part B. The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 are given to healthy participants. The purpose of Part B of this study is to understand the amount of PF-07328948 that would be available in the body after taking a single pill. The amount will be compared to the amount of PF-07328948 in a suspension in healthy adults. Part B will be conducted if the results of Part A support further study of PF-07328948. The study is seeking participants who: * are females who are not able to give birth to a child of 18 years of age or older. * are males of 18 years of age or older. * have a BMI of 20.0 to 35.0 kg/m2. * have total body weight of more than 50 kg (110 lbs). Participants in Part A will be randomly selected to receive either PF-07328948 or placebo (a pill that has no medicine in it). Participants in Part B will receive PF-07328948 as suspension and tablet form, both taken by mouth after food or during fasting. For a given participant in Part A, the total study is going to last up to about 12 weeks. This includes from the time of selection till the last follow-up phone call. The participants will be selected if they are fit for the study 28 days before the first dose of the study medicines. Participants who are selected will be admitted to the study site on Day -2 for around 19 days. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given. For a given participant in Part B, the total study is going to last up to about 10-12 weeks. Participants will stay overnight at the CRU for 23 days (Sequence 1) or 18 days (Sequence 2), starting with check-in. In Sequence 1, there will be a minimum of 10 days between doses in Period 1 and 2, and at least 7 days between doses in Period 2 and Period 3. In Sequence 2, there will be a minimum of 7 days between each dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions every 12 hour (BID) over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions BID over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions daily (QD) over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions QD over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions every QD over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions QD over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions QD over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions QD over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions QD over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions QD over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions every 12 hour (BID) or everyday (QD) over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions every 12 hour (BID) or everyday (QD) over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions QD over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions QD over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
DRUG	PF-07328948	Single doses of PF-07328948 will be administered as oral suspension (single dose) and oral tablet (single dose) under fed and fasted condition
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions QD over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions QD over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
DRUG	Placebo	Placebo will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
DRUG	PF-07328948	PF-07328948 will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days

Timeline

• Start date: 2023-04-05
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2023-04-11
• Last updated: 2024-07-19

Locations

2 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study