Effect of Genetic Variation in the Transporter OCT2, MATE1 and MATE2-K on the PKPD of Metformin

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. The investigators will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), and the multidrug and toxin extrusion transporters, MATE1, MATE2-K to test the hypothesis that genetic variation in hOCT2, hMATEE1 and hMATE2-K are associated with variation in the pharmacokinetics and/or pharmacodynamics of the antidiabetic agent, metformin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Subjects self-identify racial background, identify themselves, parents and four grandparents as Caucasian and or Chinese.

• Subject status is healthy volunteer from the SOPHIE cohort

• Subjects over 18 years old

• Subjects who are healthy on the basis of medical history, physical examinations and laboratory tests if healthy volunteer from SOPHIE

• Subjects who agree with the written informed consent to participate in the study.

Exclusion Criteria:

• Under 18 years old

• Pregnant or lactating woman (female subjects will have a urine pregnancy test at the Day 1 visit)

• They report a prior history of any allergic reaction to metformin

• Has a risk of congestive heart failure requiring pharmacologic treatment (medical history)

• Has a prior history of renal* or hepatic dysfunction (renal and hepatic function will be evaluated based on screening blood tests conducted prior to study enrollment)

• Anemic (screening lab values, hemoglobin <10 g)

• Taking a medication that could confound study results (such as known substrates or inhibitors of OCT2, MATE1 and MATE2-K such as cimetidine)

• Subjects are undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function

• They do not consent to participate in the study