NCT06161220

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

A Three-Way Crossover Thorough QT/QTc Study to Evaluate the Electrocardiographic Effects of a Supratherapeutic Dose of Carbidopa in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiac Repolarization in Healthy Subjects

Interventions

Type	Name	Description
DRUG	Carbidopa capsule	Dose: 4x 100 mg
DRUG	Moxifloxacin Tablets, USP	Dose: 400 mg
DRUG	Placebo	Placebo capsules matching the carbidopa capsules

Timeline

• Start date: 2023-10-30
• Primary completion: 2023-12-03
• Completion: 2023-12-05
• First posted: 2023-12-07
• Last updated: 2024-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study