A Study to Understand the Effect of Multiple Ascending Doses of PF-07293893 in Healthy Adult Participants

Healthy Participants Clinical Trial

Official title: A PHASE 1, MULTI-PART RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-07293893 IN HEALTHY ADULT PARTICIPANTS

Status Recruiting

Clinical Trial Summary

This study has four parts: Part A, Part B, Part C, and Part D.

The purpose of Part A of this study is to learn about the:

• safety,

• tolerability,

• how PF-07293893 is processed by the body when multiple doses of PF-07293893 are given to healthy participants.

The purpose of Part B of this study is to understand the effect of multiple doses of PF-07393893 on the amount of midazolam when given as a single dose by mouth.

The purpose of part C of this study is to understand how PF-07293893 is changed in the body and how much PF-07293893 and it's changed forms are being removed in urine and feces after a single dose given to single participants.

The purpose of Part D is to understand the effect of multiple doses of PF-07293893 on the amount of glycogen (storage form of glucose) in the muscle of healthy participants.

Part B, C and D will be done if the results of Part A support further study of PF-07293893.

The study is seeking participants who:

• are females who are not able to give birth to a child. These female participants should be between 18 to 65 years of age.

• are males of 18 to 65 years of age.

• have a body mass index (BMI) of 20.0 to 35.0 kilograms per squared meter.

• have total body weight of more than 45 kilograms (99 pounds).

For a given participant in Part A, the total study is going to last up to about 11 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 1 for around 18 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 11 weeks. This study consists of 4 periods. Participants will be admitted to the study site on Day 1 and discharged on Day 3 in period 4. 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 in period 4. 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 in period 4.

For a given participant in Part C, the total study is going to last up to about 9 weeks. Participants will be admitted to the study site on Day 1. The participants will be discharged on Day 11 after giving 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 D, the total study is going to last up to about 11 weeks. 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 -3 for around 17 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Healthy Participants

• NCT number: NCT06177457
• Study type: Interventional
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Status: Recruiting
• Phase: Phase 1
• Start date: December 20, 2023
• Completion date: October 17, 2024