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This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose | Experimental |
| |
| Part 2: Bioavailability and Food Effect | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indoximod HCL (F2) tablets | Drug | The doses will be ascending per cohort from 600 mg to 2400 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve | Part 2 | up to 20 Days |
| Pharmacokinetics: Serum concentrations (Cmax/Steady State) | Part 2 | up to 20 Days |
| Pharmacokinetics: Serum concentrations (Cmax/Steady State) | Part 1 | up to 4 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with adverse events | Part 1 | up to 18 Days |
| Percentage of patients with adverse events | Part 2 | up to 36 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Kennedy, MD | NewLink Genetics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical Services, Inc. | Secaucus | New Jersey | 07407 | United States |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Indoximod base formulation | Drug | Single oral administration of 1200 mg |
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| Placebo | Other | The matching placebo doses will be ascending per cohort from 1 to 4 tablets |
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| Indoximod HCL (F2) tablets | Drug | Single oral administration of 1200 mg |
|