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

NCT01416259 | Completed

• 1 other identifier: APPA C2011-01
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

QTc Prolongation

Outcome Measures

Primary Outcomes (1)

• QTc Prolongation

  To evaluate the effect of APF530 given subcutaneously, in normal volunteers, on placebo subtracted change of QTcF

  From baseline over 48 hours.

Secondary Outcomes (1)

• Plasma concentrations of granisetron

  From baseline over 48 hours

Study Arms (1)

APF530 Exposure, Granisetron and Moxifloxacin, Placebo

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

Drug: Withdraw treatment

Interventions

Withdraw treatment DRUG

APF530 Exposure, Granisetron and Moxifloxacin, Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Male and Female Subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Withholding Treatment

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Albert Dietz, MD, PhD

  Spaulding Clinical Research LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 15, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)