Interaction Between St John's Wort and Metformin?

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 1

Conditions: Depression; Type 2 Diabetes

Treatments: Other: St John's Wort; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01726764

AKF-382

Details and patient eligibility

About

The goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile following this possible interaction.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men aged 18-64 years
• Homozygous for common genetic variants in the genes organic cation transporter 1/2 (OCT1/OCT2)
• Normal values of biomarkers accounting for: Liver and kidney function, and normal blood glucose

Exclusion criteria

• Chronic alcohol abuse
• Hypersensitivity to metformin or St John's Wort
• Daily intake of drugs requiring prescription

Trial design

20 participants in 1 patient group

Metformin

Experimental group

Description:

7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated. Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again

Treatment:

Other: St John's Wort

Drug: Metformin