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PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA

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

NCT02113163•Thetis Pharmaceuticals LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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;
+2 more criteria

Locations (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

June 1, 2014

Completion Date

July 1, 2014

Last Updated

May 2, 2022

Enrollment

ESTIMATED participants

Conditions

Diabetes Mellitus, Non-Insulin-DependentHypertriglyceridemia

Interventions

Metformin Eicosapentaenoate

DRUG

Metformin HCl and Vascepa

DRUG

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

NCT06822790

Hypertriglyceridemia

View study

COMPLETEDNA

Technology Intensified Diabetes Education Study in African Americans

NCT02088658

Diabetes Mellitus, Type 2Diabetes Mellitus, Adult-Onset+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA

Inclusion Criteria

Exclusion Criteria

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Technology Intensified Diabetes Education Study in African Americans

A Study of SHR-1918 In Participants With Hypertriglyceridemia

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Chia Seeds Consumption in Hypertriglyceridemia