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

Heron Therapeutics

Status: Completed

Conditions: Healthy

Treatments: Drug: Withdraw treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT01416259

APPA C2011-01

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

56 participants in 1 patient group

APF530 Exposure, Granisetron and Moxifloxacin, Placebo

Description:

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

Treatment:

Drug: Withdraw treatment