Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-27 @ 2:55 PM
Study NCT ID:
NCT02342067
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination
Sponsor:
Tobira Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Multiple-Dose, Open-Label, Randomized, Crossover Study in Healthy Subjects to Assess the Effect of Pioglitazone (PGZ) on the Pharmacokinetics (PK) of Cenicriviroc Mesylate (CVC) and the Effect of CVC on the PK of PGZ
Status:
COMPLETED
Status Verified Date:
2015-05
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:
A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK of PGZ administered with and without CVC.
Detailed Description:
This is a open-label, fixed-sequence, 3-period study being conducted in a single center to evaluate the following:
* PK of CVC administered with and without PGZ
* PK of PGZ administered with and without CVC
* Safety of CVC administered with and without PGZ
* Tolerability of CVC administered with and without PGZ
* PK of CVC administered with and without PGZ
* PK of PGZ administered with and without CVC
* Safety of CVC administered with and without PGZ
* Tolerability of CVC administered with and without PGZ
Study Oversight
Has Oversight DMC:
False
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?: