COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416259
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : August 4, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Healthy Drug: Withdraw treatment

Layout table for study information
Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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 Start Date : July 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Male and Female Subjects

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416259

Layout table for location information
United States, Wisconsin
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Heron Therapeutics
Layout table for investigator information
Principal Investigator: Albert Dietz, MD, PhD Spaulding Clinical Research LLC
Layout table for additonal information
Responsible Party: Heron Therapeutics Identifier: NCT01416259    
Other Study ID Numbers: APPA C2011-01
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015
Keywords provided by Heron Therapeutics:
QTc Prolongation