A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
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.
Details
Lead Sponsor:
Heron Therapeutics
Treatments:
Fluoroquinolones Granisetron Moxifloxacin Norgestimate, ethinyl estradiol drug combination