Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189
| Status: | Archived |
|---|---|
| Conditions: | Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2011 |
| End Date: | May 2011 |
A Phase 1, Randomized, Subject Single Blinded, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of NSI-189 Phosphate in Healthy Subjects
This is a subject single blinded, randomized, placebo-controlled, single dose,
first-time-in-human study with three or more ascending cohorts.
Each subject will undergo Screening (Day -28 to Day -2). Subjects will return to the
clinical site on Day -1, be admitted to the unit, and eligibility will be reconfirmed.
Eligible subjects will receive a single dose of investigational medicinal product (IMP,
NSI-189 Phosphate or Placebo) on Day 1 and will be followed for safety and PK until
discharge on Day 3. Subjects who are experiencing any significant AEs that are considered
possibly related to study drug will be kept at the unit for an additional day (or longer)
until the event resolves or it is considered medically safe for the subject to be
discharged. Subjects will have a telephone Follow-up on Day 4 and return to the unit on Day
7 (± 1) for End-of-study. Participation of an individual subject may last up to 36 days from
the time of Screening until the End-of-study.
We found this trial at
1
site
Click here to add this to my saved trials
