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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01471717 | Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects | PHASE1 | COMPLETED | 32 | — | — | Oct 1, 2011 | Nov 1, 2011 | Jun 22, 2012 | 1 | United States |
PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination: maximum observed plasma concentration (Cmax), time at which Cmax is observed (Tmax), plasma concentration at the end of dosing interval (Ctau), area under the plasma concentration-time curve from time 0 to the end of dosing interval (AUC0-tau), elimination half-life (t1/2), apparent oral clearance (CL/F), and apparent oral volume of distribution (Vz/F), as applicable
Safety will be monitored by PEs, VS, clinical laboratory tests (including blood chemistry, CBC with differential, Troponin I, creatinine phosphokinase, and urinalysis), ECGs, and AE assessments.
| Arm | Type | Description |
|---|---|---|
| C 1:INX-08189 50 mg qd X 5 days | EXPERIMENTAL | Cohort 1: Subjects will begin administration of INX-08189 50 mg every day (QD) on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose. |
| C1: INX-08189 / Victrelis 800 mg TID X 3 days | ACTIVE_COMPARATOR | Cohort 1:INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg three times a day (TID) for 3 additional days |
| C2: Victrelis 800 mg TID x 3 days | ACTIVE_COMPARATOR | Cohort 2: Subjects will begin administration of Victrelis 800 mg three times a day (TID) on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days |
| C 2:Victrelis 800 mg TID with INX-08189 50 mg QD | ACTIVE_COMPARATOR | Cohort 2: Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days |
| C1: Placebo with Victrelis 800 mg | PLACEBO_COMPARATOR | Cohort 1: Placebo QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days |
| C 2: Victrelis 800 mg with Placebo | PLACEBO_COMPARATOR | Cohort 2: Victrelis 800 mg TID will be administered concurrently with Placebo QD for 5 additional days |
| Name | Type | Description |
|---|---|---|
| INX-08189 50 mg QD X 5 days | DRUG | Cohort 1: Subjects will begin administration of INX-08189 50 mg QD on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose. |
| INX-08189 / Victrelis 800 mg TID X three days | DRUG | Cohort 1: INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days (Study Days 5 through 7) |
| Victrelis 800 mg TID x 3 days | DRUG | In Cohort 2, subjects will begin administration of Victrelis 800 mg TID on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days (Study Days 0 through 2). |
| Victrelis 800 mg TID with INX-08189 50 mg QD | DRUG | Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days (Study Days 3 through 7). |
| Placebo with Victrelis 800 mg | DRUG | During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food. |
| Cohort 2: Victrelis 800 mg with Placebo | DRUG | During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food. |
Inclusion Criteria: Subjects must meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Study Day 0 (Visit 3): 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...