Trials / Completed
CompletedNCT02804568
A Phase 1 Safety Study in Adults With Schizophrenia
A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 3831 | Oral capsule, daily administration |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2016-06-17
- Last updated
- 2016-09-22
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02804568. Inclusion in this directory is not an endorsement.