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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Withdraw treatment

Drug

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Heron Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Aug 15, 2011
Registry last updated: Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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