Status:
COMPLETED
Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects
Lead Sponsor:
Zydus Therapeutics Inc.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.
Detailed Description
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on D...
Eligibility Criteria
Inclusion
- Males, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- History of a minimum of 1 bowel movement per day.
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- Known hypersensitivity to either saroglitazar magnesium or other PPAR agonists, and/or the excipients in the saroglitazar magnesium formulation.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). History of cholecystectomy will not be allowed.
- Subjects with congenital nonhemolytic hyperbilirubinemia (eg, suspicion of Gilbert's syndrome based on total and direct bilirubin).
- History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
- Alcohol consumption of \> 14 units per week. One unit of alcohol equals 12 oz (360 mL) of beer, 1½ oz (45 mL) of liquor, or 5 oz (150 mL) of wine.
- Positive urine drug screen at Screening or positive alcohol breath test result or positive urine drug screen at Check-in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test ( Appendix 2).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing or 5 times the t1/2 (whichever is longer).
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-in, or positive cotinine at Screening or Check-in.
- Receipt of blood products within 2 months prior to Check-in.
- Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study investigating saroglitazar magnesium, and have previously received the investigational product.
- Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
- Subjects who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR) recommended levels considered safe, per United States (US) Title 21 CFR 361.1: less than 5,000 mrem whole-body annual exposure with consideration given to the half-lives of the previous radiolabeled study drugs received.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04112446
Start Date
September 20 2019
End Date
October 29 2019
Last Update
November 13 2019
Active Locations (1)
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1
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704