Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807490
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2023-03-29
Brief Title:
A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 200 to 350 kgm2
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
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 200 to 350 kgm2
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509054-54-00 | REGISTRY | CTIS EU | None |