Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04564612
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2020-09-21
Brief Title:
Study of BIIB091 Formulations in Healthy Participants
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
An Open-Label Pharmacokinetic Study to Evaluate the Pharmacokinetics and Relative Bioavailability of BIIB091 Formulations and to Assess the Impact of Food a Proton Pump Inhibitor and CYP3A4 Inhibitor on BIIB091 Exposure Using the Selected Formulation in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-04
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 primary objectives of this study are to evaluate the pharmacokinetic PK profiles of BIIB091 modified release MR formulations in healthy participants after single dose administration in the fasted state Part 1 to evaluate the PK profile of the BIIB091 immediate release IR tablet formulation in healthy participants after single dose administration Part 1B to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a proton pump inhibitor PPI compared to healthy participants not taking a PPI to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a cytochrome P450 CYP3A4 inhibitor compared to healthy participants not taking a CYP3A4 inhibitor Part 2 to evaluate the PK of the selected BIIB091 regimen in healthy participants after multiple dose administration Part 3
The secondary objectives of this study are to determine the relative bioavailability of a single dose of the BIIB091 MR formulations compared to that of the IR drug in capsule DiC reference formulation in healthy participants in the fasted state to assess the safety and tolerability of single doses of BIIB091 when administered as MR formulations in healthy participants in the fasted state Part 1 to determine the PK of a single dose of the BIIB091 IR tablet formulation in the fed and fasted state in healthy participants to evaluate the PK profiles of the BIIB091 IR tablet formulation in healthy participants after administration of divided total daily doses over a 24 hour period in the fasted or fed state to determine the relative bioavailability of a single dose or divided dose of the BIIB091 IR tablet formulation compared to that of the IR DiC reference formulation in healthy participants in the fasted state to determine the PK of a single or divided dose of the BIIB091 IR tablet formulation administered with an alternative meal composition in healthy participants to assess the safety and tolerability of a single or divided dose of BIIB091 when administered as the IR tablet formulation and IR DiC reference formulation in healthy participants in fed or fasted state Part 1B to confirm the PK profiles of the selected BIIB091 regimen in healthy participants after single dose administration and to establish a reference exposure for the assessment of drug interaction to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a PPI to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a CYP3A4 inhibitor Part 2 to assess the safety and tolerability of multiple doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants Part 3
The secondary objectives of this study are to determine the relative bioavailability of a single dose of the BIIB091 MR formulations compared to that of the IR drug in capsule DiC reference formulation in healthy participants in the fasted state to assess the safety and tolerability of single doses of BIIB091 when administered as MR formulations in healthy participants in the fasted state Part 1 to determine the PK of a single dose of the BIIB091 IR tablet formulation in the fed and fasted state in healthy participants to evaluate the PK profiles of the BIIB091 IR tablet formulation in healthy participants after administration of divided total daily doses over a 24 hour period in the fasted or fed state to determine the relative bioavailability of a single dose or divided dose of the BIIB091 IR tablet formulation compared to that of the IR DiC reference formulation in healthy participants in the fasted state to determine the PK of a single or divided dose of the BIIB091 IR tablet formulation administered with an alternative meal composition in healthy participants to assess the safety and tolerability of a single or divided dose of BIIB091 when administered as the IR tablet formulation and IR DiC reference formulation in healthy participants in fed or fasted state Part 1B to confirm the PK profiles of the selected BIIB091 regimen in healthy participants after single dose administration and to establish a reference exposure for the assessment of drug interaction to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a PPI to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a CYP3A4 inhibitor Part 2 to assess the safety and tolerability of multiple doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants Part 3
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 |
|---|---|---|---|
| 2020-000682-16 | EUDRACT_NUMBER | None | None |