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NCT01416259 · ClinicalTrials.gov registry record
A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
A clinical trial, sponsored by Heron Therapeutics.
- Completed
- Registry status
- 56
- Enrollment target
NCT01416259: Completed study, sponsored by Heron Therapeutics.
NCT01416259 is a clinical trial that has completed, run by Heron Therapeutics. The registered enrollment target is 56 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416259 has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
Study Summary
This Phase I study will be performed in a double-blind, randomized, crossover design in healthy male and female subjects. The central ECG laboratory will be blinded to treatment. Every effort will be made to enroll equal numbers of males and females into the study. Eligible subjects will participate in a screening phase (within 28 days of the dosing day), a treatment phase and a final visit, which will be conducted on discharge from the study. Study duration will be 32 days with a total of approximately 12 days of confinement. During the resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at selected time points to assess potential ECG effects. Blood samples for PK evaluation will be collected in conjunction with the ECG time points.
Primary Outcome
To evaluate the effect of APF530 given subcutaneously, in normal volunteers, on placebo subtracted change of QTcF
Interventions
- DRUG Withdraw treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-10 |
What the finished NCT01416259 record still lists
NCT01416259 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 56 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Withdraw treatment is the first listed.
NCT01416259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01416259 about?
NCT01416259 is a clinical study titled "A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin". This Phase I study will be performed in a double-blind, randomized, crossover design in healthy male and female subjects. The central ECG laboratory will be blinded to treatment. Every effort will be made to enroll equal numbers of males and females into the study. Eligible subjects will participat...
What is the current status of trial NCT01416259?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2011-07. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01416259?
The interventions under investigation include: Withdraw treatment (DRUG).
Who is sponsoring clinical trial NCT01416259?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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