Cypress, California 90630

  • Healthy Volunteers

Purpose:

To compare the bioavailability and pharmacokinetic profiles of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers


Study summary:

Part 1: To compare the bioavailability and pharmacokinetic profiles of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers; and To choose one of the two MN-166 50mg ER tablet formulations for evaluation in Part 2. Secondary: To determine the safety and tolerability of the two formulations of MN-166 ER tablets in a single-dose regimen in healthy volunteers. Part 2: To compare the bioavailability and steady-state pharmacokinetic profile of MN-166 50mg ER tablet with MN-166 10mg capsules in a multiple-dose regimen in healthy volunteers; and Secondary: To determine the safety and tolerability of MN-166 ER tablets in a multiple-dose regimen in healthy volunteers


Criteria:

Inclusion Criteria: 1. Able to provide written informed consent. 2. Healthy non-smoking male and female subjects aged 18 to 65 years, inclusive. 3. No clinical abnormalities in laboratory and urine analyses. 4. Normal renal function (GFR > 90mL/min). 5. Liver enzymes should be less than twice the upper limit of normal (ULN). 6. Screening electrocardiogram (ECG) with QT interval adjusted for heart rate within normal limits. 7. Agree to use barrier contraceptive methods during the course of the study (hormonal contraceptive alone is not acceptable). 8. Females of child-bearing potential must have a negative pregnancy test on Study Day 1. Exclusion Criteria: 1. Known hypersensitivity to Pinatos® or its components. 2. Condition(s) which might affect drug absorption, metabolism or excretion. 3. Untreated mental illness, current drug addiction or abuse or alcoholism. 4. Donated blood in the past 90 days or have poor peripheral venous access. 5. Platelets < l00,000/mm3, history of thrombocytopenia. 6. Confirmed diagnosis of chronic liver disease, e.g., chronic Hep. B, Hep. C infection, auto-immune, alcoholic or neoplastic liver disease. 7. Positive serostatus for HIV. 8. Currently pregnant or nursing. 9. History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric diseases. 10. Received an investigational drug in the past 30 days. 11. Unable to swallow tablets.


NCT ID:

NCT03533387


Primary Contact:

Principal Investigator
Robina Smith, MD
WCCT Global, Inc.


Backup Contact:

N/A


Location Contact:

Cypress, California 90630
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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