Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/27/2019 |
| Start Date: | March 5, 2018 |
| End Date: | August 14, 2018 |
A Phase 1, Randomized Trial to Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (Part 2) in Healthy Male Volunteers
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.
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.
Inclusion Criteria:
- Non-smoker for at least 3 months
- BMI within 18 to 30 kg/m2
- Able to speak, read, and understand English or Spanish
Exclusion Criteria:
- Clinically significant cardiac, pulmonary, hepatic or renal disease
- History of substance abuse or alcohol dependence within past 2 years
- Inability to fast for a minimum of 14 hours
- Inability to swallow large capsules/tablets
- Pending legal charges or is on probation
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