Ignite Creation Date:
2024-05-06 @ 3:01 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02182375
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2014-07-02
Brief Title:
Effect of BI 201335 Mediated UGT1A1 Uridine-diphosphate-glucuronosyltransferases Inhibition in Healthy Volunteers
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open Label Fixed Sequence Phase I Study to Investigate the Effect of BI 201335 Mediated UGT1A1 Inhibition on the Multiple Oral Dose Pharmacokinetics of Raltegravir Isentress in Healthy Male and Female Volunteers
Status:
COMPLETED
Status Verified Date:
2014-07
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:
Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI 201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to investigate safety and tolerability
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