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NCT02636842
A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder
Phase 1 trial testing Aripiprazole Lauroxil in Schizophrenia in 47 participants. Completed in 1 June 2016.
1 June 2016
Quick facts
| Lead sponsor | Alkermes, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 1 December 2015 |
| Primary completion | 1 June 2016 |
| Estimated completion | 1 June 2016 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Aripiprazole Lauroxil (ARIPIPRAZOLE LAUROXIL) — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
Sponsor
Alkermes, Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum plasma concentration (Cmax)
Time frame: Up to 7 days
Sponsor's own description
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02636842
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aripiprazole Lauroxil
Trials testing the same drug.
- NCT05662306 — C-Cog in Early Course Schizophrenia Study · Phase 4 · terminated
- NCT04203056 — Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode · Phase 4 · terminated
- NCT03345979 — A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia · Phase 3 · completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
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- NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
- NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
- NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
- NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting
Other Alkermes, Inc. trials
Trials by the same sponsor.
- NCT06555783 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 · Phase 2 · completed
- NCT06358950 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) · Phase 2 · completed
- NCT05547100 — Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan · Phase 1 · completed
- NCT05019105 — Phase 1 ALKS 1140 in Healthy Adults · Phase 1 · terminated
- NCT04987658 — Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02636842 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alkermes, Inc.
- Last refreshed: 13 July 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02636842.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing