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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113163
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Thetis Pharmaceuticals LLC

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Hypertriglyceridemia Drug: Metformin Eicosapentaenoate Drug: Metformin HCl and Vascepa Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cohort A - Low Dose
Metformin Eicosapentaenoate 1500 mg or Metformin HCl 500 mg and Vascepa 1000 mg
Drug: Metformin Eicosapentaenoate
Drug: Metformin HCl and Vascepa
Active Comparator: Cohort B - High Dose
Metformin Eicosapentaenoate 3000 mg or Metformin HCl 1000 mg and Vascepa 2000 mg
Drug: Metformin Eicosapentaenoate
Drug: Metformin HCl and Vascepa



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113163


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Thetis Pharmaceuticals LLC
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Responsible Party: Thetis Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT02113163    
Other Study ID Numbers: TP-101-CS01
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Keywords provided by Thetis Pharmaceuticals LLC:
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
Additional relevant MeSH terms:
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Hypertriglyceridemia
Diabetes Mellitus, Type 2
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases
Metformin
Eicosapentaenoic acid ethyl ester
Hypoglycemic Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Lipid Regulating Agents