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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01416259

Enrollment

Registered

2011-08-15

Start date

2011-07-01

Completion date

2011-10-01

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

QTc Prolongation

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.

Interventions

DRUGWithdraw treatment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
QTc Prolongation	From baseline over 48 hours.	To evaluate the effect of APF530 given subcutaneously, in normal volunteers, on placebo subtracted change of QTcF

Secondary

Measure	Time frame	Description
Plasma concentrations of granisetron	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlbert Dietz, MD, PhD

Spaulding Clinical Research LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026