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

NCT06161220 | Completed Phase 1 FDA Drug

• 1 other identifier: IPX203-102-23
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline QTcF (ΔQTcF)

  Change-from-baseline QTcF ( QTcF) will allow evaluation of the effects of carbidopa and moxifloxacin on cardiac repolarization based on model derived placebo-corrected ΔQTcF (ΔΔQTcF).

  Predose to 24 hours postdose

Secondary Outcomes (1)

• Change from baseline HR, PR, and QRS

  Predose to 24 hours postdose

Study Arms (3)

Carbidopa capsule

EXPERIMENTAL

Dose: 4x 100 mg

Drug: Carbidopa capsule; Drug: Moxifloxacin Tablets, USP; Drug: Placebo

Moxifloxacin Tablets, USP

ACTIVE COMPARATOR

Dose: 400 mg

Drug: Carbidopa capsule; Drug: Moxifloxacin Tablets, USP; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Carbidopa capsule; Drug: Moxifloxacin Tablets, USP; Drug: Placebo

Interventions

Carbidopa capsule DRUG

Dose: 4x 100 mg

Carbidopa capsule; Moxifloxacin Tablets, USP; Placebo

Moxifloxacin Tablets, USP DRUG

Dose: 400 mg

Carbidopa capsule; Moxifloxacin Tablets, USP; Placebo

Placebo DRUG

Placebo capsules matching the carbidopa capsules

Carbidopa capsule; Moxifloxacin Tablets, USP; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females aged 18 to 55 years (both inclusive)
• For female subjects of childbearing potential, use of double contraception method
• Body Mass Index (BMI) 18.5 to \<30 kg/m² at Screening, with a minimum weight of 55kg
• Subject with no clinically significant abnormal serum biochemistry, hematology and urine examination values at screening
• Subject with negative urine screen for drugs of abuse at screening
• Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results at screening
• Subject must be willing to communicate with the investigator and site staff and comply with all study procedures and requirements
• Subject must be able to provide written, informed consent including compliance with the requirements listed in the consent form
• Subject must be able and willing to swallow whole capsules without breaking, cutting, or chewing

You may not qualify if:

• History or presence of systemic diseases at Screening, which as judged by the investigator, may affect the outcome of this study, include, but not limited to significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
• Female subjects who are pregnant or lactating
• Knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders
• Resting supine heart rate less than 50 beats per minute or greater than 100 beats per minute
• Resting supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg; resting supine diastolic blood pressure less than 50 mmHg or greater than 90 mmHg.
• Clinically significant (as determined by the Investigator) ECG abnormalities at Screening, including:
• 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
• Any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant

Sponsors & Collaborators

• Impax Laboratories, LLC: lead

Study Sites (1)

AXIS Clinicals, LLC

Dilworth, Minnesota, 56529-1342, United States

Location

MeSH Terms

Interventions

Carbidopa

Intervention Hierarchy (Ancestors)

Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded (for test and negative control) and open label (for active control)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: October 30, 2023
• Primary Completion: December 3, 2023
• Study Completion: December 5, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (1)