Status:
COMPLETED
A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
Lead Sponsor:
Heron Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01416259
Start Date
July 1 2011
End Date
October 1 2011
Last Update
August 4 2015
Active Locations (1)
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1
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095