A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | July 2011 |
| End Date: | October 2011 |
A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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