Heart safety check for nausea drug in healthy volunteers

NCT ID NCT01416259

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Spaulding Clinical Research

    West Bend, Wisconsin, 53095, United States

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