Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-07 @ 8:18 PM
Study NCT ID:
NCT03116893
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2017-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Effect of P-gp Inhibition, OATP-inhibition and Food on the Kinetics of a Single Oral Dose BI 685509 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2017-06
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 this trial is to investigate the relative bioavailability of BI 685509 given alone under fasted conditions (Reference, R) compared to the intake after a high fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted conditions (Test 3, T3).
The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
Detailed Description:
BI 685509 is a substrate of the drug transporters P-gp and Organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1/OATP1B3). Inhibition of these transport proteins may result in an increased drug exposure which might impact the safety of the patients. Therefore this trial should investigate whether and to what extent the inhibition of P-gp (mediated by itraconazole) and the inhibition of OATP1B1/OATP1B3 (mediated by rifampin) affects kinetics of BI 685509. Itraconazole and rifampin are recommended probe drugs to test in-vivo inhibition of P-gp and OATP1B1/OATP1B3.
Furthermore the food effect will be investigated in this study.
Furthermore the food effect will be investigated in this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-003310-27 | EUDRACT_NUMBER | None | View |