Pharmacokinetics, Safety, and Tolerability of SYN-020
Status:
Completed
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
Summary
This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK,
safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy
adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will
participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg
SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will
receive doses that were well tolerated in an earlier cohort to determine the effect of BMI
and/or a high-fat meal on the SYN-020 PK profile.
For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive
study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before
dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be
discharged from the clinic after the End of Study procedures are completed on Day 6.