Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INX-08189 · 3 trials · 2 indications
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 |
| Arm 1: INX-08189 (9 mg) or Placebo | EXPERIMENTAL | - |
| Arm 2: INX-08189 (25 mg) or Placebo | EXPERIMENTAL | - |
| Arm 3: INX-08189 (50 mg + 9 mg) or Placebo | EXPERIMENTAL | - |
| Arm 4: INX-08189 (50 mg) or Placebo | EXPERIMENTAL | - |
| Arm 5: INX-08189 (9 mg) or Placebo + Ribavirin | EXPERIMENTAL | - |
| Arm 6: INX-08189 (25 mg) or Placebo + Ribavirin | EXPERIMENTAL | - |
| Arm 7: INX-08189 (100 mg) or Placebo | EXPERIMENTAL | - |
| 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 | Capsules, Oral, 9 mg, Once Daily, 7 Days |
| Placebo matching with INX-08189 | DRUG | Capsules, Oral, 0 mg, Once daily, 7 days |
| Ribavirin | DRUG | Capsules, Oral, 1000 or 1200 mg daily (delivered in weight-adjusted am/pm divided dose), 7 days |
| 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...
INX-08189 is an investigational small molecule being developed for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. It has been studied in healthy subjects and in treatment-naive patients with chronic HCV genotype 1 infection.
INX-08189 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY.
INX-08189 is in Phase 1 clinical development. It has completed Phase 1 trials, but it remains an investigational drug and has not been approved by the FDA.
INX-08189 has completed three Phase 1 clinical trials. NCT01159808 studied single ascending oral doses in healthy subjects. NCT01250366 evaluated safety and pharmacokinetics in treatment-naive HCV genotype 1 patients. NCT01471704 investigated a pharmacokinetic interaction with verapamil in healthy volunteers.
INX-08189 is the primary name used in clinical trials. No alternative names have been reported for this investigational compound.
INX-08189 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available clinical trial information.