Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507904
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Antacid in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Crossover Design Study to Assess Palatability of Osivelotor PF-07940367 Pediatric Formulations With Dosing Vehicle Part 1 and Randomized Single-Dose Parallel Design Study to Estimate Relative Bioavailability of Osivelotor Pediatric Formulation With Dosing Vehicle and With Water Compared to Clinical Tablet Formulation and Effect of Food andor Acid-Reducing Agent On Bioavailability In Healthy Adult Participants Part 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study to learn how different preparations of Osivelotor taste and enter the blood with food or liquids or with an antacid in healthy adults
Detailed Description:
This study has two parts Part 1 and Part 2 The purpose of Part 1 of this study is to learn how different preparations of the study medicine called osivelotor PF-07940367 taste The purpose of Part 2 of this study is to learn how the study medicine is taken up into the blood when mixed with
soft foods or liquids given on an empty stomach or
with an acid-reducing agent in healthy adults
This study is seeking participants who are
healthy females and males of 18 to 65 years of age
have a body mass index of 16 to 32 kilogram per meter squared
have a total body weight of more than 50 kilograms 110 pounds
Participants in Part 1 of the study will receive the study medicine 4 times with at least 2-hour interval on day one This study medicine will not be swallowed but will be placed in the mouth and spat out The participants will then complete a short questionnaire 4 times over 20 minutes All study medicines will be given in the study clinic
Participants in Part 2 of the study will receive the study medicine up to 2 times The first dose of the study medicine will be swallowed The second dose the study medicine if given will not be swallowed but will be placed in the mouth and spat out for the taste questionnaire as above All study medicines will be given in the study clinic
In Part 1 participants will be involved in this study for up to 2 months During this time there will be a two-day stay in the study clinic After leaving the clinic study team will also call participants once over the phone Woman who could become pregnant may need to visit the study clinic instead of receiving a phone call
In Part 2 participants will be involved in this study for up to 4 months During this time there will be a seven-day stay in the study clinic After leaving the clinic the study team will also call participants 3 times over the phone Woman who could become pregnant may need to visit the study clinic instead of receiving a phone calls
In both parts blood and urine tests will be done and blood pressures and heart traces taken Also contraception requirements will need to be followed to prevent pregnancy during the study
soft foods or liquids given on an empty stomach or
with an acid-reducing agent in healthy adults
This study is seeking participants who are
healthy females and males of 18 to 65 years of age
have a body mass index of 16 to 32 kilogram per meter squared
have a total body weight of more than 50 kilograms 110 pounds
Participants in Part 1 of the study will receive the study medicine 4 times with at least 2-hour interval on day one This study medicine will not be swallowed but will be placed in the mouth and spat out The participants will then complete a short questionnaire 4 times over 20 minutes All study medicines will be given in the study clinic
Participants in Part 2 of the study will receive the study medicine up to 2 times The first dose of the study medicine will be swallowed The second dose the study medicine if given will not be swallowed but will be placed in the mouth and spat out for the taste questionnaire as above All study medicines will be given in the study clinic
In Part 1 participants will be involved in this study for up to 2 months During this time there will be a two-day stay in the study clinic After leaving the clinic study team will also call participants once over the phone Woman who could become pregnant may need to visit the study clinic instead of receiving a phone call
In Part 2 participants will be involved in this study for up to 4 months During this time there will be a seven-day stay in the study clinic After leaving the clinic the study team will also call participants 3 times over the phone Woman who could become pregnant may need to visit the study clinic instead of receiving a phone calls
In both parts blood and urine tests will be done and blood pressures and heart traces taken Also contraception requirements will need to be followed to prevent pregnancy during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None