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.
ConditionDiabetes Mellitus, Non-Insulin-Dependent
Hypertriglyceridemia
InterventionDrug: Metformin Eicosapentaenoate
Drug: Metformin HCl and Vascepa
PhasePhase 1
SponsorThetis Pharmaceuticals LLC
Responsible PartyThetis Pharmaceuticals LLC
ClinicalTrials.gov IdentifierNCT02113163
First ReceivedApril 10, 2014
Last UpdatedApril 10, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateApril 10, 2014
Last Updated DateApril 10, 2014
Start DateMarch 2014
Estimated Primary Completion DateJuly 2014
Current Primary Outcome MeasuresAUC 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 MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitlePK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
Official TitleAn 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Hypertriglyceridemia
InterventionDrug: Metformin Eicosapentaenoate
Drug: Metformin HCl and Vascepa
Study Arm (s)
  • Active Comparator: Cohort A - Low Dose
    Metformin Eicosapentaenoate 1500 mg or Metformin HCl 500 mg and Vascepa 1000 mg
  • Active Comparator: Cohort B - High Dose
    Metformin Eicosapentaenoate 3000 mg or Metformin HCl 1000 mg and Vascepa 2000 mg

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment32
Estimated Completion DateJuly 2014
Estimated Primary Completion DateJune 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Lauren Harrington, RN
225-763-2699
Lauren.Harrington@pbrc.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT02113163
Other Study ID NumbersTP-101-CS01
Has Data Monitoring CommitteeYes
Information Provided ByThetis Pharmaceuticals LLC
Study SponsorThetis Pharmaceuticals LLC
CollaboratorsNot Provided
Investigators Not Provided
Verification DateApril 2014

Locations[ + expand ][ + ]

Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Principal Investigator: Frank Greenway, MD
Recruiting