Influence of CYP2D6 polymorphism on metoprolol pharmacokinetics and pharmacodynamics in human volunteers MedDRA version: 18.0 Level: HLGT Classification code 10007521 Term: Cardiac arrhythmias System Organ Class: 10007541 - Cardiac disorders MedDRA version: 18.0 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: metoprolol tartraat
Product Name: metoprolol tartraat
Pharmaceutical Form: Capsule
INN or Proposed INN: Metoprolol
Other descriptive name: METOPROLOL TARTRATE
Concentration unit: mg millig
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent and willing to comply with the study restrictions • Healthy male or female subjects aged between 18 and 40 years • Non-smoking, with no clinically relevant abnormalities • Agree to abstain from caffeine (including coffee, tea, chocolate, or caffeine-containing soft drinks) intake from 24 hours prior to the first dose until the end of the study • The subject is willing and able to abstain from grapefruit, grapefruit juice or any other grapefruit-containing products for 72 hours prior to the first dose of study drug until the end of the study • Body weight greater than or equal to 45 kilogram (kg) at screening • Be able to refrain from strenuous physical exercise from 48 hours prior to each dosing period. • No significant ECG abnormalities. 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Concomitant clinical significant diseases at baseline, e.g., known cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc. • Resting heart rate less than 45 bpm and blood pressure less than 105/60 millimeter of mercury (mmHg) • Have a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human peptides or proteins • Pregnancy or childbearing potential without adequate contraception • Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year • No blood donating or blood loss within 60 days prior to screening or plasma donating within 7 days prior screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: not applicable;Primary end point(s): Vital signs (pulse rate in bpm, systolic and diastolic blood pressure in mmHg, electrocardiogram), plasma concentration of metoprolol;Timepoint(s) of evaluation of this end point: At baseline, 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours after administration;Main Objective: To educate students about the full life cycle of clinical trials including study set-up, design, execution, analysis and reporting To explore the influence of CYP2D6 polymorphism on the pharmacodynamics and pharmacokinetics of metoprolol in healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy of metoprolol compared to placebo, measured in vital signs (pulse rate, blood pressure and ECG);Timepoint(s) of evaluation of this end point: At baseline, 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours after administration | — |
Countries
Netherlands
Contacts
Public ContactClinical trials
Centre for Human Drug Research
Outcome results
None listed