Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 9:51 AM
Study NCT ID:
NCT01471704
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2011-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Phase 1b, Drug-Drug Interaction Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2012-06
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:
INX-189-005
Brief Summary:
The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL ER).
Detailed Description:
This is a single-center, open-label, single-sequence, crossover, drug-drug interaction study in healthy subjects.
Primary Objectives:
Safety
\- To evaluate the safety of a single dose of INX-08189 (50 mg) alone and combined with verapamil HCL ER (240 mg) after subjects receive verapamil HCL ER QD for 6 days
Pharmacokinetic
\- To evaluate the effect of multiple doses of verapamil HCL ER (240 mg) on the pharmacokinetic (PK) profile of INX-08189 and the metabolite INX-08032, and the effect of a single dose of INX-08189 on the PK profile of verapamil and the metabolite norverapamil
Primary Objectives:
Safety
\- To evaluate the safety of a single dose of INX-08189 (50 mg) alone and combined with verapamil HCL ER (240 mg) after subjects receive verapamil HCL ER QD for 6 days
Pharmacokinetic
\- To evaluate the effect of multiple doses of verapamil HCL ER (240 mg) on the pharmacokinetic (PK) profile of INX-08189 and the metabolite INX-08032, and the effect of a single dose of INX-08189 on the PK profile of verapamil and the metabolite norverapamil
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| INH-189-005 | OTHER | INH-189-005 | View |