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

NCT02113163 | Completed Phase 1 DMC

• 1 other identifier: TP-101-CS01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent; Hypertriglyceridemia

Keywords

Type 2 diabetes; T2DM; hypertriglyceridemia; severe hypertriglyceridemia; dyslipidemia; triglycerides; lipids; omega-3 fatty acids; EPA; ethyl-EPA; Metformin; Glucophage; Lovaza; Vascepa; Epanova; Astra Zeneca; Amarin; GSK

Outcome Measures

Primary Outcomes (1)

• AUC following single and repeat single oral administration of metformin eicosapentaenoate, metformin hydrochloride and Vascepa

  PK samples at 0, 0.5, 1, 2, 4, 8, and 12 hours following drug administration

Study Arms (2)

Cohort A - Low Dose

ACTIVE COMPARATOR

Metformin Eicosapentaenoate 1500 mg or Metformin HCl 500 mg and Vascepa 1000 mg

Drug: Metformin Eicosapentaenoate; Drug: Metformin HCl and Vascepa

Cohort B - High Dose

ACTIVE COMPARATOR

Metformin Eicosapentaenoate 3000 mg or Metformin HCl 1000 mg and Vascepa 2000 mg

Drug: Metformin Eicosapentaenoate; Drug: Metformin HCl and Vascepa

Interventions

Metformin Eicosapentaenoate DRUG

Cohort A - Low Dose; Cohort B - High Dose

Metformin HCl and Vascepa DRUG

Cohort A - Low Dose; Cohort B - High Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thetis Pharmaceuticals LLC: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertriglyceridemia; Dyslipidemias

Interventions

Metformin; eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (1)