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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics
ClinicalTrials.gov Identifier:
NCT01416259
First received: August 10, 2011
Last updated: October 24, 2012
Last verified: October 2012

August 10, 2011
October 24, 2012
July 2011
October 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01416259 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy Male and Female Subjects

Healthy
Drug: Withdraw treatment
APF530 Exposure, Granisetron and Moxifloxacin, Placebo
Arm 1:APF530 Exposure Arm 2:Granisetron IV Arm 3:Moxifloxacin Arm 4:Placebo
Intervention: Drug: Withdraw treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01416259
APPA C2011-01
No
Heron Therapeutics
Heron Therapeutics
Not Provided
Principal Investigator: Albert Dietz, MD, PhD Spaulding Clinical Research LLC
Heron Therapeutics
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP