A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
Completed · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01416259
- Run by
- Heron Therapeutics
- People needed
- 56
- Starts
- 2011-07-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects in good health
- aged between 18-50 years
- weigh at least 50 kg (110 pounds)
- have a body mass index of 18-32 kg/m2 inclusive
- capable of understanding and complying with the protocol
- have signed the informed consent
You may not qualify if…
- have a history of drug abuse or are current smokers
- have a known hypersensitivity to Moxifloxacin or granisetron
- a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of > 450 ms in men, > 470 ms in women on the screening ECG
- PR > 240 ms, QRS > 110 ms or a history of prolongation of QT interval
- a family history of Long QT Syndrome or cardiac disease
- may not have used any medications or consumed any foods contraindicated in the protocol
Where it is running
- Spaulding Clinical Research — West Bend, Wisconsin, United States
Full record on ClinicalTrials.gov
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