Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640933
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Open-Label Single-Dose 6-Period Crossover Study to Evaluate the Pharmacokinetics of BIIB091 Formulations and the Effect of Food in Healthy Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
In this study researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food One new form of BIIB091 is an extended release tablet also known as ER This form helps release BIIB091 slowly and consistently helping to keep steady drug levels in the body for longer The other new form is a gastro-retentive tablet also known as GR This form has a special coating that swells and allows BIIB091 to stay in the stomach longer For both GR and ER tablets there are also slow and fast forms that change how quickly BIIB091 is released into the body But eating food with these tablets may affect how much BIIB091 is in the body
The main objective of this study is to learn how 2 new forms of BIIB091 which are released into the body at different rates are processed in the body Researchers also want to learn how these new forms compare to the immediate release tablet also known as IR This form delivers BIIB091 immediately into the body
The main question researchers want to answer in this study is
How does the body process different tablet forms of BIIB091 with or without food
Researchers will also learn more about
How the body processes the 2 new tablet forms of BIIB091 with food compared to the IR tablet form with food
How the body processes the ER tablet form of BIIB091 with food compared to without food
Any medical problems the participants have during the study
Any changes in the participants overall health during the study
This study will be done as follows
Participants will be screened to check if they can join the study The screening period will be up to 22 days after which eligible participants will check into their study research center
Participants will be randomly assigned to 1 of 6 groups In each group the participants will take the below tablet forms but in different orders
Immediate-Release IR
Gastro-Retentive slow GR-slow
Gastro-Retentive fast GR-fast
Extended-Release slow ER-slow
Extended-Release fast ER-fast
ER-slow without food
Each period includes the participant taking a single dose of what they were assigned to There will be 3 days of no dosing in each period The participant will then move to the next tablet form assigned This will continue until each participant has taken a single dose of each of the 6 tablet forms
Participants will remain at their study research center for 25 days for the treatment periods Afterwards there will be a follow-up phone call 7 to 10 days after each participants last dose Each participant will be in the study for up to 53 days
The main objective of this study is to learn how 2 new forms of BIIB091 which are released into the body at different rates are processed in the body Researchers also want to learn how these new forms compare to the immediate release tablet also known as IR This form delivers BIIB091 immediately into the body
The main question researchers want to answer in this study is
How does the body process different tablet forms of BIIB091 with or without food
Researchers will also learn more about
How the body processes the 2 new tablet forms of BIIB091 with food compared to the IR tablet form with food
How the body processes the ER tablet form of BIIB091 with food compared to without food
Any medical problems the participants have during the study
Any changes in the participants overall health during the study
This study will be done as follows
Participants will be screened to check if they can join the study The screening period will be up to 22 days after which eligible participants will check into their study research center
Participants will be randomly assigned to 1 of 6 groups In each group the participants will take the below tablet forms but in different orders
Immediate-Release IR
Gastro-Retentive slow GR-slow
Gastro-Retentive fast GR-fast
Extended-Release slow ER-slow
Extended-Release fast ER-fast
ER-slow without food
Each period includes the participant taking a single dose of what they were assigned to There will be 3 days of no dosing in each period The participant will then move to the next tablet form assigned This will continue until each participant has taken a single dose of each of the 6 tablet forms
Participants will remain at their study research center for 25 days for the treatment periods Afterwards there will be a follow-up phone call 7 to 10 days after each participants last dose Each participant will be in the study for up to 53 days
Detailed Description:
The primary objective of this study is to characterize the pharmacokinetics PK of BIIB091 after a single oral dose of different BIIB091 formulations with or without food conditions in healthy participants
The secondary objectives of this study are to compare the exposure of BIIB091 after a single oral dose of 4 new BIIB091 formulations GR-fast GR-slow ER-fast ER-slow with a moderate-fat meal versus a single oral dose of BIIB091 IR tablets with a moderate-fat meal in healthy participants to compare the exposure of BIIB091 after a single oral dose of BIIB091 ER-slow formulation with a moderate-fat meal versus under fasting conditions in healthy participants to evaluate the safety and tolerability of BIIB091 after a single oral dose of different BIIB091 formulations with or without food conditions in healthy participants
The secondary objectives of this study are to compare the exposure of BIIB091 after a single oral dose of 4 new BIIB091 formulations GR-fast GR-slow ER-fast ER-slow with a moderate-fat meal versus a single oral dose of BIIB091 IR tablets with a moderate-fat meal in healthy participants to compare the exposure of BIIB091 after a single oral dose of BIIB091 ER-slow formulation with a moderate-fat meal versus under fasting conditions in healthy participants to evaluate the safety and tolerability of BIIB091 after a single oral dose of different BIIB091 formulations with or without food conditions in healthy participants
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