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Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects will be randomized to receive either placebo or 20 mg INV-101 |
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| Cohort 2 | Experimental | Subjects will be randomized to receive either placebo or 80 mg INV-101 |
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| Cohort 3 | Experimental | Subjects will be randomized to receive either placebo or 160 mg INV-101 |
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| Cohort 4 | Experimental | Subjects will be randomized to receive either placebo or 320 mg INV-101 |
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| Cohort 5 | Experimental | Subjects will be randomized to receive either placebo or 500 mg INV-101 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INV-101 | Drug | Subjects will be randomized to receive INV-101 tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters - Maximum Concentration (Cmax) | Cmax following single dose | 72 hours |
| Pharmacokinetic parameters - AUC | AUC following single dose | 72 hours |
| Pharmacokinetic parameters - Half-live | Half-live following single dose | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Safety of INV-101 following single dose | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Montreal | Quebec | Canada |
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Fully blinded
| Placebo | Drug | Subjects will be randomized to receive placebo tablets |
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