AV-101 Alone and in Combination With Probenecid in Healthy Subjects
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This is an open-label, two period, fixed-sequence, drug-drug interaction study to compare the
PK and PD of orally administered AV-101 alone and in combination with probenecid in healthy
subjects. In Treatment Period 1, subjects will receive AV-101 following an overnight fast of
at least 8 hours. In Treatment Period 2, subjects will fast overnight for at least 8 hours,
and then receive AV-101 2 hours after receiving 1,000 mg probenecid. Each Treatment Period
will be separated by a washout period. The doses of AV-101 in Cohort 1 and a possible Cohort
2 will be 360 mg and 720 mg, respectively. Optional Cohorts 3 and 4 may be enrolled depending
on results from Cohorts 1 and 2. CSF will be collected via indwelling catheter to determine
the PK of AV-101 and its active metabolite 7-Cl-KYNA.