CompletedPhase 1

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

United States32 participantsStarted 2014-03

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT02113163

SponsorThetis Pharmaceuticals LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06

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