A randomized, double blind, crossover, placebo controlled class-room experiment to assess the pharmacodynamics and pharmacokinetics of metoprolol in healthy volunteers with different polymorphism of CYP2D6

Phase 4

Recruiting

• Conditions: CYP2D6 polymorphism; 10082206

• Registration Number: NL-OMON42822
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Eligible subjects must meet all of the following inclusion criteria at screening:
1. Signed informed consent and willing to comply with the study restrictions
2. Healthy male or female subjects aged between 18 and 40 years
3. Non-smoking, with no clinically relevant abnormalities
4. Agree to abstain from caffeine (example, coffee, tea, chocolate, or caffeine-containing soft drinks) intake during the inpatient portion of the study
5. 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 studie.
6. Body mass index between 18 and 32 kilogram per square meter (kg/m2) and body weight greater than or equal to 50 kilogram (kg) at screening
7. Be able to refrain from strenuous physical exercise from 48 hours prior to each dosing period.

Exclusion Criteria

Eligible subjects must meet none of the following exclusion criteria at screening:
1. Contraindication to metoprolol tartrate immediate release (metoprolol IR)
2. Unacceptable known concomitant diagnoses or diseases at baseline, e.g., known cardiovascular or pulmonary disease, renal or liver dysfunction, ECG abnormalities, etc.
3. Resting heart rate less than 50 bpm and blood pressure less than 110/70 millimeter of mercury (mmHg)
4. History of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
5. 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
6. Pregnancy or childbearing potential without adequate contraception
7. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year
8. No blood donating or blood loss within 60 days prior to screening or plasma donating within 7 days prior screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic endpoints<br /><br><br /><br>- maximum concentration (Cmax) with the different blood sampling data<br /><br>- the time to reach this concentration (tmax)<br /><br>- the half-life time (t1/5), the time in which half of the dose is eliminated<br /><br><br /><br><br /><br>Pharmacodynamic endpoints<br /><br><br /><br>- heart rate with a pulse measurement<br /><br>- heart rhythm with an electro cardiogram (ECG)<br /><br>- blood pressure with a blood pressure monitor</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic endpoints<br /><br><br /><br>- heart rate with a pulse measurement<br /><br>- heart rhythm with an electro cardiogram (ECG)<br /><br>- blood pressure with a blood pressure monitor</p><br>