Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01471704 | Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2011 | Nov 1, 2011 | Jun 22, 2012 | 1 | United States |
| NCT01159808 | A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects | PHASE1 | COMPLETED | 42 | — | — | May 1, 2010 | Oct 1, 2010 | Jun 22, 2012 | - | — |
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).
Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, electrocardiogram (ECG) and vital signs assessments
Safety will be evaluated on the basis of adverse event (AE) incidence, changes in serum chemistry and hematology values, urinalysis results, and changes in vital signs and in electrocardiogram (ECG) findings.
Including a determination of maximum observed plasma concentration (Cmax), time at which the maximum plasma concentration was observed (Tmax), time at which concentrations are first measurable in the plasma (Tlag), area under the plasma concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-last) and elimination half-life (T 1/2) after single ascending oral doses.
The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated
| Arm | Type | Description |
|---|---|---|
| INX-08189 50 mg | EXPERIMENTAL | Study Day 0: Single 50 mg dose of INX-08189 in the morning |
| 240 mg verapamil HCL ER | ACTIVE_COMPARATOR | Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning |
| INX-08189 50 mg & verapamil HCLER 240 mg | ACTIVE_COMPARATOR | Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning |
| INX-08189 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| INX-08189 50 mg | DRUG | Study Day 0: Single 50 mg dose of INX-08189 in the morning |
| 240 mg verapamil HCL ER | DRUG | Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning |
| 50 mg dose of INX-08189 and 240 mg verapamil HCL ER | DRUG | Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning |
| INX-08189 | DRUG | 3, 25 and 100 mg capsules; oral administration, single dose |
| Placebo | DRUG | matching placebo capsules, oral administration, single dose |
Inclusion Criteria: Subjects must meet the following criteria at the screening visit (Visit1) and Visit 2 in order to be eligible for study drug administration: 1. Must be a healthy male or female between 18 and 55 years of age (inclusive) with body mass index (BMI) between 18 and 30 kg/m2 (inclus...