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NCT01606436 · ClinicalTrials.gov registry record · Phase 1
A Study Measuring Effect of LY2140023 (Pomaglumetad Methionil) on Electrocardiographs in Participants With Schizophrenia
A Phase 1 study of Schizophrenic Disorders, sponsored by Denovo Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 8
- Study locations
NCT01606436: Completed Phase 1 study of Schizophrenic Disorders, sponsored by Denovo Biopharma.
NCT01606436 is a Phase 1 study of Schizophrenic Disorders that has completed, run by Denovo Biopharma. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01606436, a Phase 1 study of Schizophrenic Disorders, has completed, sponsored by Denovo Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study determined if a single dose of LY2140023 (pomaglumetad methionil) affects the electrical activity in the heart in participants with schizophrenia. This study also helped determine how a single high dose of LY2140023 is tolerated by participants.
Primary Outcome
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QT intervals from quadruplicate electrocardiogram (ECG) data were corrected for heart rate using Fridericia's formula: QTcF = QT/RR\^0.333, where RR is the interval between two R waves. Least squares (LS) mean changes from baseline in QTcF were calculated using a mixed-effects model with baseline QTcF, treatment, time, period, sequence, and the time-by-treatment interaction as fixed effects and pa
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG LY2140023
Study Locations (8)
California
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Garden Grove
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - San Diego
Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - North Miami
Kansas
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Overland Park
Maryland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Rockville
Missouri
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St Louis
Pennsylvania
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Philadelphia
Texas
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01606436 record still lists
NCT01606436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 1 condition, with Schizophrenic Disorders appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01606436 lists 8 locations in 7 states (California, Florida, Kansas).
Frequently Asked Questions
What is clinical trial NCT01606436 about?
NCT01606436 is a clinical study titled "A Study Measuring Effect of LY2140023 (Pomaglumetad Methionil) on Electrocardiographs in Participants With Schizophrenia". This study determined if a single dose of LY2140023 (pomaglumetad methionil) affects the electrical activity in the heart in participants with schizophrenia. This study also helped determine how a single high dose of LY2140023 is tolerated by participants.
What is the current status of trial NCT01606436?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2012-06. Estimated completion is 2012-09.
What conditions does trial NCT01606436 study?
This clinical trial studies the following conditions: Schizophrenic Disorders.
What interventions are being tested in trial NCT01606436?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), LY2140023 (DRUG).
Who is sponsoring clinical trial NCT01606436?
This trial is sponsored by Denovo Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01606436 being conducted?
This trial has 8 study locations across California, Florida, Kansas, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01606436's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 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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