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NCT01495169 · ClinicalTrials.gov registry record · Phase 1
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
A Phase 1 study of Safety and Tolerability of Iloperidone, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 10
- Study locations
NCT01495169: Completed Phase 1 study of Safety and Tolerability of Iloperidone, sponsored by Vanda Pharmaceuticals.
NCT01495169 is a Phase 1 study of Safety and Tolerability of Iloperidone that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495169, a Phase 1 study of Safety and Tolerability of Iloperidone, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 10
- Study locations
Study Summary
Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication
Primary Outcome
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing. From the plasma concentration data, AUC, Cmax ss, and Tmax ss are calculated.
Conditions Studied
Interventions
- DRUG iloperidone (oral tablet)
Study Locations (10)
Ohio
- Novartis Investigative Site - Cincinnati
- Novartis Investigative Site - Cleveland
California
- Novartis Investigative Site - Costa Mesa
Florida
- Novartis Investigative Site - North Miami
Georgia
- Novartis Investigative Site - Atlanta
Idaho
- Novartis Investigative Site - Coeur d'Alene
Maryland
- Novartis Investigative Site - Baltimore
Missouri
- Novartis Investigative Site - St Louis
New Jersey
- Novartis Investigative Site - Marlton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT01495169 record still lists
NCT01495169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Safety and Tolerability of Iloperidone appearing as the primary indexed condition, and to 1 intervention - of which iloperidone (oral tablet) is the first listed.
NCT01495169 lists 10 locations in 9 states (Ohio, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01495169 about?
NCT01495169 is a clinical study titled "Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients". Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication
What is the current status of trial NCT01495169?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2011-10. Estimated completion is 2015-02.
What conditions does trial NCT01495169 study?
This clinical trial studies the following conditions: Safety and Tolerability of Iloperidone.
What interventions are being tested in trial NCT01495169?
The interventions under investigation include: iloperidone (oral tablet) (DRUG).
Who is sponsoring clinical trial NCT01495169?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01495169 being conducted?
This trial has 10 study locations across California, Florida, Georgia, Idaho, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01495169's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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