Interaction Between St John's Wort and Metformin?

NCT01726764 | Completed Phase 1

• 1 other identifier: AKF-382
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Oral glucose tolerance test (OGTT)

  During the first 2 hours of each metformin ingestion

• Pharmacokinetics of metformin

  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

• Change in messenger RiboNucleic Acid (mRNA)

  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)

Other Outcomes (1)

• Hypericin/hyperforin

  At t=0 in 2nd period

Study Arms (1)

Metformin

EXPERIMENTAL

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

Other: St John's Wort; Drug: Metformin

Interventions

St John's Wort OTHER

Metformin

Metformin DRUG

Metformin

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark

Odense, DK-5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression

Interventions

Hypericum extract LI 160; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Per Damkier, MD ph.d.

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Tore B. Stage, M.Sc. Pharm

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Kim Brøsen, Professor, MD

  University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc. Pharm

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 15, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: May 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DK (1)