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| ID | Type | Description | Link |
|---|---|---|---|
| INX-189-004 | Other Identifier | INX-189-004 |
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This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).
This is a single-center, randomized, placebo-controlled study in thirty-two 18 to 55 year old, male and female, healthy adult volunteers.
Primary Objectives:
Pharmacokinetic
Safety
- To evaluate the safety of INX-08189 and Victrelis when dosed alone and when dosed in combination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| 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 |
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| 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 |
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| C1: Placebo with Victrelis 800 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of INX-08189, INX-08032, and Victrelis when dosed alone and in combination | 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 | INX-08189: C1: Days 4 & 7; C2: Day 7 pre-dose & 15, 30, & 45 minutes, & 1, 2, 3, 4, 6, 8, 10, 12, 16, & 24 hours after dosing. Victrelis: C2: Days 2 & 7; C1: Day 7 pre-dose & 0.5, 1, 2, 3, 4, 6, & 8 hours after AM dose. Up to 72 hours after last dose. |
| Safety parameters, including adverse event, concurrent medication, clinical laboratory, ECG, PE, and VS assessments | 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. | Study Day 1 to 8, and Study Day 14 |
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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):
Exclusion Criteria:
Subjects must NOT meet the following criteria at the Screening Visit (Visit1), in order to be eligible for study drug administration at Study Day 0 (Visit 3):
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Campaneria, MD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research, LLC | Saint Paul | Minnesota | 55114 | United States |
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| Placebo Comparator |
Cohort 1: Placebo QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days |
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| 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 |
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| 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) |
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| 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). |
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| 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). |
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| 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. |
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| 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. |
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| ID | Term |
|---|---|
| C553340 | BMS-986094 |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
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