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| ID | Type | Description | Link |
|---|---|---|---|
| INH-189-001 | Other Identifier | INH-189-001 |
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The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INX-08189 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INX-08189 | Drug | 3, 25 and 100 mg capsules; oral administration, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects | 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. | periodically over 14 days |
| Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects | 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. | periodically over 14 days |
| Assess the effect of a high fat meal on the PK parameters | The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated | periodically over 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Boehlecke, MD, MSPH | Study Director |
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| ID | Term |
|---|---|
| C553340 | BMS-986094 |
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| Placebo |
| Drug |
matching placebo capsules, oral administration, single dose |
|