Trials / Completed
CompletedNCT06194552
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
A Multiple Ascending Dose, Phase 1, Double-Blind, Study to Investigate the Safety and Pharmacokinetics of NTRX-07 in Healthy Volunteers and Patients With Early Alzheimer's Disease (AD), With an Exploratory Fed-Fasted Assessment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- NeuroTherapia, Inc. · Industry
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study of the effect of a high fat meal was conducted.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NTRX-07 | Investigational orally administered CB2 agonist |
| DRUG | Placebo | Matched placebo administered orally |
Timeline
- Start date
- 2022-09-06
- Primary completion
- 2023-05-31
- Completion
- 2023-06-30
- First posted
- 2024-01-08
- Last updated
- 2024-01-08
Locations
2 sites across 2 countries: United States, Hungary
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06194552. Inclusion in this directory is not an endorsement.