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

NCT01416259 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2026-02-12

No results posted yet for this study

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

Interventions

DRUG

Withdraw treatment

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Principal Investigators

  • Albert Dietz, MD, PhD · Spaulding Clinical Research LLC

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416259 on ClinicalTrials.gov