A class-room experiment to investigate the genetic differences regarding effects of metoprolol in human volunteers

Conditions: Influence of CYP2D6 polymorphism on metoprolol pharmacokinetics and pharmacodynamics in human volunteers
MedDRA version: 18.0Level: HLGTClassification code 10007521Term: Cardiac arrhythmiasSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 18.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2015-002265-36-NL

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

•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.