Development of CYP2D6 genotype based dosage guidelines for the beta-blockers metoprolol and carvedilol based on hepatic clearance and resting and exercise heart rate reduction - MCCD

Phase 1

• Conditions: Healthy male and female volunteers

• Registration Number: EUCTR2004-002754-62-DE
• Lead Sponsor: niversity of Göttingen; Dep. of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-08
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

All male and female healthy volunteers aged between 18 and 50 years with normal body weight are eligible for this study.

The required pre-conditions in detail:

-Age: 18-50 years
-Caucasian (German origin), African or Asian
-Bodyweight 50 – 100 kg and BMI 18 – 25 kg/m²
-Non smokers and ex smokers with abstinence >2 month
-Willingness to meet the study instructions and to co-operate with the study personal
-Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Volunteers taking any medication before or during the trial are excluded from the study. Taking oral contraceptive drugs is also an exclusion criterion.

Exclusion criteria in detail are:

-Age < 18 years or > 50 years
-Known pregnancy or lactation period
-Any significant abnormality in the ECG, any known or hint on any cardiac disease including any abnormality in auscultation except of the abnormality is judged clinically insignificant by a cardiologist
-Significant abnormalities as result of the medical-screening-laboratory-analysis, especially of the liver and kidney related parameters.
-Any disease affecting liver or kidney or impairment of the liver or kidney-function
-Asthma
-Known Raynod’s syndrome
-Any major acute disease or fever (Temp. > 37,5 °C).
-Any major gastrointestinal disease and any gastrointestinal disorder that is expected to significantly interfere with the pharmacokinetics of the study drug
-Gastrointestinal surgery (except appendectomy or herniotomy)
-Participation in any other clinical study or donation of blood within 4 weeks before the start of this study
-Current smokers or having ever smoked more than 1 pack year
-Taking any medication before or during the trial including oral contraceptive drugs
-Alcohol and drug addiction or any abusive use of medicaments
-Any other findings that could compromise the safety of the participant or the quality of the study-results

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified