Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT03943056
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2019-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
Status:
COMPLETED
Status Verified Date:
2021-03
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 will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).
Detailed Description:
Initial protocol recruitment and follow up was completed by 10 Jan 2020 with an optional cohort intended for completion by April 2020. Subsequently, a decision was made not to progress this optional cohort in light of COVID-19 which has resulted in a delay in reporting the actual completion date.
Study Oversight
Has Oversight DMC:
False
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?: