Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbidopa capsule | Experimental | Dose: 4x 100 mg |
|
| Moxifloxacin Tablets, USP | Active Comparator | Dose: 400 mg |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbidopa capsule | Drug | Dose: 4x 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline HR, PR, and QRS | Change from baseline HR, PR, and QRS (ΔHR, ΔPR, ΔQRS) will also be measured to allow evaluation of the effects of carbidopa and moxifloxacin on other ECG parameters based on model derived placebo-corrected ΔHR, ΔPR, and ΔQRS (ΔΔHR, ΔΔPR, and ΔΔQRS). | Predose to 24 hours postdose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
Positive urine/serum drug screen at Screening or Day -1 for each Period
History of significant alcohol abuse or drug abuse within one year prior to Screening.
Use of prescription medication (with the exception of medically approved hormonal contraceptives) including MAO inhibitors in the 30 days prior to admission into Period 1 and over-the-counter medications including vaccines, vitamins, and herbal remedies within 14 days prior to admission of Period 1 till completion of the study (EOS or ET)
History of unexplained loss of consciousness, unexplained syncope, unexplained irregular heartbeats or palpitations or near drowning with hospital admission
Subjects who received any investigational drug within the longer of 30 days or 5 half-lives of Day 1 dosing of SM
Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study
Use of medications in the 90 days before admission of the study that are known to prolong the QT/QTc interval.
Family history of QTc prolongation or of unexplainable sudden death at <50 years of age. For this study, family is defined as 1st degree relative (i.e., mother, father, siblings, children) or 2nd degree relative (grandparents, grandchildren, half-siblings, aunt/uncle, niece/nephew).
Subjects who cannot refrain from using tobacco of any kind within 30 days prior to admission (Day -1) of Period 1 until the last blood sample collection of study
Subjects who cannot refrain from consumption of alcohol or alcohol containing products or xanthine-containing foods or beverages (like chocolate, tea, coffee or cola drinks) within 48 hours prior to admission (Day -1) of Period 1 till the last blood sample collection of study
Subjects who participate in other drug research study during the study.
Subjects who cannot refrain from donating blood or plasma for 30 days and 14 days (respectively) prior to dosing, during the study, and for at least 4 weeks after completing the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AXIS Clinicals, LLC | Dilworth | Minnesota | 56529-1342 | United States |
Not provided
| ID | Term |
|---|---|
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D008750 | Methyldopa |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
Not provided
Not provided
Not provided
Not provided
Not provided
Double blinded (for test and negative control) and open label (for active control)
| Moxifloxacin Tablets, USP | Drug | Dose: 400 mg |
|
| Placebo | Drug | Placebo capsules matching the carbidopa capsules |
|
| D009930 |
| Organic Chemicals |
| D006834 | Hydrazines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |