Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003829
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2023-07-26
Brief Title:
A Study to Learn About the Tastes of Different Suspensions With the Study Medicine PF-07923568 in Healthy Adult Participants
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A RANDOMIZED PHASE 1 SINGLE-BLIND MULTI-PERIOD STUDY TO INVESTIGATE THE PALATABILITY OF PF-07923568 ORAL SUSPENSION IN DIFFERENT LIQUID VEHICLES IN HEALTHY ADULT PARTICIPANTS
Status:
COMPLETED
Status Verified Date:
2023-10
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:
The purpose of this study is to learn about the tastes of different suspensions with the study medicine called PF-07923568 in healthy adult participants In a suspension the medicine is mixed with a liquid usually water in which it cannot dissolve and therefore remains intact in the form of small particles
This study is seeking for healthy participants who
are aged 18 years of age or older
can produce a baby must agree to use a highly effective method of birth control
are confirmed to be healthy by some medical tests This study can include both men and women
have body mass index BMI of 16 to 32 kgm2 and a total body weight of more than 45 kilograms
Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two days to see if they are good to taste Participants will answer a questionnaire after tasting each suspension The questionnaire will be completed for each suspension The questionnaire asks participants to test each suspension at 4 different times after tasting and spitting out the suspension At least 60 minutes will pass between tasting each suspension
The total planned time period of participation is around 5 to 8 weeks This includes the screening period of up to 28 days Followed by first administration of study medicine Then a 3 day in-patient stay at the study clinic It also includes a follow-up phone call that happens 28-35 days after the final taste test
This study is seeking for healthy participants who
are aged 18 years of age or older
can produce a baby must agree to use a highly effective method of birth control
are confirmed to be healthy by some medical tests This study can include both men and women
have body mass index BMI of 16 to 32 kgm2 and a total body weight of more than 45 kilograms
Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two days to see if they are good to taste Participants will answer a questionnaire after tasting each suspension The questionnaire will be completed for each suspension The questionnaire asks participants to test each suspension at 4 different times after tasting and spitting out the suspension At least 60 minutes will pass between tasting each suspension
The total planned time period of participation is around 5 to 8 weeks This includes the screening period of up to 28 days Followed by first administration of study medicine Then a 3 day in-patient stay at the study clinic It also includes a follow-up phone call that happens 28-35 days after the final taste test
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 |
|---|---|---|---|
| 2023-504924-24-00 | REGISTRY | CTIS EU | None |