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 \- 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
24
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
Prism Research, LLC
Saint Paul, Minnesota, United States
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.