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The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if there are differences in these parameters when HQK-1001 is administered in a fed versus a fasted state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | HQK-1001 |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HQK-1001 | Drug | HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam | 41 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics assessed by plasma drug concentration levels | 15 days | |
| Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin | 41 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Downey, MD | Charles River Clinical Services Northwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles River Clinical Services Northwest | Tacoma | Washington | 98403 | United States |
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| ID | Term |
|---|---|
| C074677 | 2,2-dimethylbutyric acid |
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| placebo |
| Drug |
Matching placebo capsules administered once a day, orally, for 14 days. |
|
| Comparison of safety, PK and PD under fed versus fasting conditions |
| 41 days |
| Comparison of safety and PK when oral iron is administered with HQK-1001. | 41 days |