A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin

Completed

• Conditions: Healthy
• Interventions: Drug: Withdraw treatment

• Registration Number: NCT01416259
• Lead Sponsor: Heron Therapeutics

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
APF530 Exposure, Granisetron and Moxifloxacin, Placebo	Withdraw treatment	Arm 1:APF530 Exposure Arm 2:Granisetron IV Arm 3:Moxifloxacin Arm 4:Placebo

Primary Outcome Measures

Name	Time	Method
QTc Prolongation	From baseline over 48 hours.	To evaluate the effect of APF530 given subcutaneously, in normal volunteers, on placebo subtracted change of QTcF

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of granisetron	From baseline over 48 hours	To achieve a mean Cmax of granisetron and AUC exposure in normal volunteers equivalent to that achieved by APF530 given subcutaneously, in patients.

Trial Locations

Locations (1)

Spaulding Clinical Research; 🇺🇸 West Bend, Wisconsin, United States