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The objectives of this study are:
Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing
Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IW-1701 | Experimental | IW-1701 tablets administered orally in multiple ascending dose. |
|
| Placebo | Placebo Comparator | Matching placebo tablets administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IW-1701 | Drug | IW-1701 Tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Event | 47 Days | |
| Maximum observed plasma concentration [Cmax] | Maximum observed Plasma Concentration | 47 Days |
| Area under the plasma concentration time curve during a dosing interval [AUC] | Area under the plasma concentration time curve during a dosing interval | 47 Days |
| Time of maximum observed plasma concentration [Tmax] | Time of maximum observed plasma concentration | 47 Days |
| Blood Pressure | 47 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Unit | San Antonio | Texas | 78209 | United States |
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| Drug |
Matching Placebo Tablet |
|