CompletedPhase 1

A TQT Study to Evaluate the Electrocardiographic Effects of Carbidopa in Healthy Subjects

United States35 participantsStarted 2023-10-30

Plain-language summary

The purpose of this trial is to assess the effects of a single supratherapeutic dose of carbidopa on cardiac repolarization relative to placebo in healthy adult subjects.

Who can participate

Age range18 Years – 55 Years

SexALL

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Exclusion criteria

✕. QTcF \> 450 ms for female and \>430 ms for male
✕. QRS \> 110 ms
✕. PR \> 200 ms
✕. QTcF \> 450 ms for female and \>430 for male
✕. QRS \> 110 ms
✕. PR \> 200 ms
✕. Resting supine HR \<50 beats per minute (bpm) or \>100 bpm (may be repeated once at the discretion of the investigator)
✕. Second or third-degree AV block

What they're measuring

Change from baseline QTcF (ΔQTcF)

Timeframe: Predose to 24 hours postdose

Trial details

NCT IDNCT06161220

SponsorImpax Laboratories, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-03

View on ClinicalTrials.gov More Cardiac Repolarization in Healthy Subjects trials