PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
Overview[ - collapse ][ - ]
Purpose | The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101. |
---|---|
Condition | Diabetes Mellitus, Non-Insulin-Dependent Hypertriglyceridemia |
Intervention | Drug: Metformin Eicosapentaenoate Drug: Metformin HCl and Vascepa |
Phase | Phase 1 |
Sponsor | Thetis Pharmaceuticals LLC |
Responsible Party | Thetis Pharmaceuticals LLC |
ClinicalTrials.gov Identifier | NCT02113163 |
First Received | April 10, 2014 |
Last Updated | April 10, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | April 10, 2014 |
---|---|
Last Updated Date | April 10, 2014 |
Start Date | March 2014 |
Estimated Primary Completion Date | July 2014 |
Current Primary Outcome Measures | AUC following single and repeat single oral administration of metformin eicosapentaenoate, metformin hydrochloride and Vascepa [Time Frame: PK samples at 0, 0.5, 1, 2, 4, 8, and 12 hours following drug administration] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA |
---|---|
Official Title | An Open-label, Single and Repeat Single Ascending Dose Escalation Study to Compare the Pharmacokinetics of Metformin Eicosapentaenoate With Metformin Hydrochloride and Icosapent Ethyl Following Oral Administration to Healthy Volunteers |
Brief Summary | The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
|
Intervention | Drug: Metformin Eicosapentaenoate Drug: Metformin HCl and Vascepa |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 32 |
Estimated Completion Date | July 2014 |
Estimated Primary Completion Date | June 2014 |
Eligibility Criteria | Inclusion Criteria: - Signed informed consent executed prior to protocol screening assessments; - Men or women 18 to 65 years of age, inclusive (Women may be surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are postmenopausal for >1 year. Women who are of childbearing potential must agree to practice adequate contraception one month before the first dose of study medication and up to Day 16 of the study. Adequate contraception may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods.); - No history of chronic diseases, except for subjects with well-controlled hypertension or well-controlled hyperlipidemia; - BMI ≤30kg/m2; - No significant medical history including diabetes or hypertension complicated by hyperlipidemia (metabolic syndrome); - Negative urine drug and alcohol tests at Screening; and, - No metformin or omega-3 products within 2 months. Exclusion Criteria: - Abnormal findings on physical examination, EKG, vital signs, and clinical laboratory testing, in the judgment of the investigator; - Allergies to fish or shellfish; - Impaired renal function (calculated eGFR <60 mL/min); - Abnormal laboratory values for T3, T4 and TSH at the Screening Visit; - Aspartate aminotransferase/alanine aminotransferase (AST/ALT) >2x upper limits of normal (ULN) or serum bilirubin >1.5 mg/dL; - Requirement of prescription medication within 14 days of the Screening Visit, with the exception of prescription medications for the prevention of pregnancy, anti hypertensives for hypertension, or statins for hyperlipidemia. Doses of one or two anti-hypertensives and/or a statin must be stable for >1 month; - Normal doses of over-the-counter medications, including vitamins are allowed but not within 3 days of Visit 2 (first day of dosing); - Current or history of abuse of alcohol or illicit drugs within the preceding year to the Screening Visit; - Participation in a dietary modification or an intensive weight loss program; - Participation in another clinical trial of an investigational product within 3 months prior to the Screening Visit; - Smokers (use of tobacco in the past 3 months); or, - Donation or loss of 400 mL blood or more in the last 8 weeks. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Contact: Lauren Harrington, RN 225-763-2699 Lauren.Harrington@pbrc.edu |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02113163 |
---|---|
Other Study ID Numbers | TP-101-CS01 |
Has Data Monitoring Committee | Yes |
Information Provided By | Thetis Pharmaceuticals LLC |
Study Sponsor | Thetis Pharmaceuticals LLC |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Pennington Biomedical Research Center | Baton Rouge, Louisiana, United States, 70808 Principal Investigator: Frank Greenway, MDRecruiting |
---|