A Study to Understand the Effect of Multiple Ascending Doses of PF-07293893 in Healthy Adult Participants
Status:
Recruiting
Trial end date:
2024-10-17
Target enrollment:
Participant gender:
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.