Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02829541
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2016-07-08
Brief Title:
A Phase 1 Single-Ascending-Dose Safety Tolerability PharmacokineticPK and PharmacodynamicPD Study of BIIB068 in Healthy Participants
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase 1 Randomized Blinded Placebo-Controlled Single-Ascending-Dose Safety Tolerability Pharmacokinetic and Pharmacodynamic Study of BIIB068 a Brutons Tyrosine Kinase Inhibitor in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants Secondary objectives are to characterize the single-oral-dose Pharmacokinetic PK of BIIB068 in healthy participants to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor PPI esomeprazole on the single-dose PK of BIIB068 in healthy participants
Detailed Description:
None
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