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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A.P. Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01416259
First received: August 10, 2011
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Withdraw treatment
 Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by A.P. Pharma, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 56
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
APF530 Exposure, Granisetron and Moxifloxacin, Placebo
Arm 1:APF530 Exposure Arm 2:Granisetron IV Arm 3:Moxifloxacin Arm 4:Placebo
 Drug: Withdraw treatment

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Male and Female Subjects

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416259

Locations
United States, Wisconsin
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
A.P. Pharma, Inc.
Investigators
Principal Investigator: Albert Dietz, MD, PhD Spaulding Clinical Research, LLC
  More Information

No publications provided

Responsible Party: A.P. Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01416259     History of Changes
Other Study ID Numbers: APPA C2011-01
Study First Received: August 10, 2011
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by A.P. Pharma, Inc.:
QTc Prolongation

Additional relevant MeSH terms:
Granisetron
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
 Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on June 18, 2013