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 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- QTc Prolongation [ Time Frame: From baseline over 48 hours. ] [ Designated as safety issue: Yes ]To evaluate the effect of APF530 given subcutaneously, in normal volunteers, on placebo subtracted change of QTcF
- Plasma concentrations of granisetron [ Time Frame: From baseline over 48 hours ] [ Designated as safety issue: No ]To achieve a mean Cmax of granisetron and AUC exposure in normal volunteers equivalent to that achieved by APF530 given subcutaneously, in patients.
|Study Start Date:||July 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
APF530 Exposure, Granisetron and Moxifloxacin, Placebo
Arm 1:APF530 Exposure Arm 2:Granisetron IV Arm 3:Moxifloxacin Arm 4:Placebo
|Drug: Withdraw treatment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416259
|United States, Wisconsin|
|Spaulding Clinical Research|
|West Bend, Wisconsin, United States, 53095|
|Principal Investigator:||Albert Dietz, MD, PhD||Spaulding Clinical Research LLC|