Trials / Terminated
TerminatedNCT04240158
IW-6463 Safety Study in Healthy Elderly Subjects
Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Tisento Therapeutics · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.
Detailed description
Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IW-6463 | IW-6463 Tablet |
| DRUG | Matching Placebo | Matching Placebo Tablet |
Timeline
- Start date
- 2020-01-06
- Primary completion
- 2020-05-22
- Completion
- 2020-05-22
- First posted
- 2020-01-27
- Last updated
- 2024-08-16
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04240158. Inclusion in this directory is not an endorsement.