Interaction Between St John's Wort and Metformin?
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Type 2 Diabetes Depression |
Intervention | Other: St John's Wort Drug: Metformin |
Phase | Phase 1 |
Sponsor | University of Southern Denmark |
Responsible Party | University of Southern Denmark |
ClinicalTrials.gov Identifier | NCT01726764 |
First Received | November 2, 2012 |
Last Updated | November 1, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | November 2, 2012 |
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Last Updated Date | November 1, 2013 |
Start Date | January 2013 |
Estimated Primary Completion Date | December 2013 |
Current Primary Outcome Measures | Change in Area Under Curve (AUC) 0-24h of metformin [Time Frame: 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] [Designated as safety issue: No]Change in 0-24h AUC of metformin after 3 weeks of treatment with St John's Wort |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Interaction Between St John's Wort and Metformin? |
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Official Title | Is There a Pharmacokinetic Interaction Between St John's Wort and Metformin? |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label |
Condition |
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Intervention | Other: St John's Wort Drug: Metformin |
Study Arm (s) | Experimental: Metformin 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 |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 22 |
Estimated Completion Date | December 2013 |
Estimated Primary Completion Date | November 2013 |
Eligibility Criteria | 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 |
Gender | Male |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01726764 |
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Other Study ID Numbers | AKF-382 |
Has Data Monitoring Committee | No |
Information Provided By | University of Southern Denmark |
Study Sponsor | University of Southern Denmark |
Collaborators | Not Provided |
Investigators | Principal Investigator: Per Damkier, MD ph.d. University of Southern DenmarkPrincipal Investigator: Tore B. Stage, M.Sc. Pharm University of Southern DenmarkStudy Director: Kim Brøsen, Professor, MD University of Southern Denmark |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark | Odense, Denmark, DK-5000 |
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