Interaction Between St John's Wort and Metformin?

Depression Clinical Trial

Official title:

Is There a Pharmacokinetic Interaction Between St John's Wort and Metformin?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726764
• Other study ID #: AKF-382
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2012
• Last updated: December 2, 2014
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depression
• Type 2 Diabetes

Intervention

Other:
• St John's Wort

Drug:
• Metformin

Locations

Country	Name	City	State
Denmark	Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypericin/hyperforin	If possible measure the concentrations of some of the active components of St John's Wort, hypericin and hyperforin	At t=0 in 2nd period	No
Primary	Change in Area Under Curve (AUC) 0-24h of metformin	Change in 0-24h AUC of metformin after 3 weeks of treatment with St John's Wort	Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion	No
Secondary	Oral glucose tolerance test (OGTT)	Changes in: Plasma-glucose, serum-insulin, glucagon-like peptide 1 (GLP-1) and connecting-peptides (C-peptides) during the oral glucose tolerance test, measured at 0, 0.5, 1, 1.5 and 2 hours after metformin ingestion.	During the first 2 hours of each metformin ingestion	No
Secondary	Pharmacokinetics of metformin	Determination of other pharmacokinetic parameters of metformin such as clearance (CL), absorption fraction (F), distribution volume (V), the minimum concentration at steady state (Css,min), elimination half life (T 1/2) etc.	Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion, which will be used to determine the pharmacokinetic parameters mentioned below	No
Secondary	Change in messenger RiboNucleic Acid (mRNA)	Changes in mRNA encoding OCT1 will be measured at 4 different time points to give an insight to the importance of St John's Wort effect on the OCT1 production	Will be measured 4 times: At inclusion (t=0 on that day), at t=0 in both periods and minimum 3 weeks after finalization of the study (t=0 on that day)	No