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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2011

Interventions

  • Drug: Withdraw treatment

Arms, Groups and Cohorts

  • APF530 Exposure, Granisetron and Moxifloxacin, Placebo
    • Arm 1:APF530 Exposure Arm 2:Granisetron IV Arm 3:Moxifloxacin Arm 4:Placebo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Plasma concentrations of granisetron
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Heron Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Albert Dietz, MD, PhD, Principal Investigator, Spaulding Clinical Research LLC

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