A Phase 1/2 interventional study of INX-08189 50 mg and 240 mg verapamil HCL ER in Healthy, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-22.
Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Health services research
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).
This is a single-center, open-label, single-sequence, crossover, drug-drug interaction study in healthy subjects.
Primary Objectives:
Safety
Pharmacokinetic
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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Subjects must meet the following criteria at the screening visit (Visit1) and Visit 2 in order to be eligible for study drug administration:
Exclusion Criteria:
Subjects must NOT meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Visit 2:
Study Day 0: Single 50 mg dose of INX-08189 in the morning
Drug: INX-08189 50 mg
Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning
Drug: 240 mg verapamil HCL ER
Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning
Drug: 50 mg dose of INX-08189 and 240 mg verapamil HCL ER
Study Day 0: Single 50 mg dose of INX-08189 in the morning
Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning
Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning
Effect of multiple doses of verapamil HCL ER 240 mg on the PK profile of INX-08189, and the effect of a single dose of INX-08189 on the PK profile of verapamil.
PK for INX-08189 and verapamil by: maximum plasma concentration (Cmax), time Cmax is observed (Tmax), plasma concentration at end of dosing (Ctau), area under plasma concentration-time curve; time 0 to last measurable plasma concentration (AUC0-last), area under plasma concentration-time curve; time 0 to infinity (AUC0-inf), area under plasma concentration-time curve; 0 to end of dosing (AUC0-tau), elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent oral volume of distribution (Vz/F).
Time frame: INX-08189 and Verapamil: Study Day 0 (INX-08189), Study Day 12 (Verapamil) and subsequently at 30 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours after dosing. INX-08189 also at 48, 72, and 96 hours after initial dose.
Safety of a single dose of INX-08189 50 mg alone & combined with verapamil HCL ER 240 mg after subjects received verapamil HCL ER QD for 6 days
Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, electrocardiogram (ECG) and vital signs assessments
Time frame: Study Day -1, during the 24-hours post-dose, Study Day 2 to 4, 5, 6, 7 to 11, 12, and 13 to 16
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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