Heart safety check for nausea drug in healthy volunteers
NCT ID NCT01416259
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether APF530, a drug for nausea, changes the heart's electrical activity (QT interval) in healthy adults. Fifty-six volunteers received APF530, a placebo, or other comparison drugs in a random order. The goal was to check for heart rhythm risks before the drug is used more widely.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
56 people
The number who actually took part.
- Start date
-
Jul 2011
- Finished
-
Oct 2011
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy Male and Female Subjects
- Ages
-
18 to 50 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Spaulding Clinical Research
West Bend, Wisconsin, 53095, United States
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