Bupropion Stereoselective Pharmacokinetics and CYP2D6 Inhibition in Healthy Volunteers
Bupropion
Disease
+ Pathologic Processes
+ Pathological Conditions, Signs and Symptoms
Basic Science Study
Summary
Study start date: June 5, 2018
Actual date on which the first participant was enrolled.This study focuses on understanding how the drug bupropion is processed in the body, specifically in healthy volunteers. Bupropion is a medication often used to help people quit smoking or manage depression. The study aims to thoroughly examine how bupropion and its byproducts behave in the body over time. Additionally, it seeks to determine how bupropion interacts with an enzyme called CYP2D6, which plays a crucial role in breaking down many medications. Participants in this study will have their blood tested to measure the levels of bupropion and its byproducts, as well as the activity of the CYP2D6 enzyme. The primary outcome of the study is to measure the exposure to bupropion and its metabolites, as well as the activity of CYP2D6, by looking at the area under the plasma concentration versus time curves. This will help researchers understand the onset, extent, and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and its metabolites.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Male and female (approximately 1:1) volunteers between the age of 18 and 55 years old and within 32% of your ideal body weight. * Judged healthy without any significant medical condition as determined by and decided from a pre-enrollment screening session that include medical history, laboratory tests such as blood and urine tests, and an electrical tracing of the heart beat (electrocardiogram, EKG). * Individuals who agree to refrain from taking any prescriptions medications, over-the-counter medications, and herbal, dietary, and alternative supplements that may interact with the metabolism of those study drugs at least 2 weeks prior to the start of the study and until study completion. * Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at least two weeks prior to and until the completion of the study (the entire study lasts for approximately 32 days). * Willing to commit the time requested for this study Exclusion Criteria: Subjects will be excluded from the study if they: * Are underweight (weigh less than 52 kg or 114 lb) or overweight \[body mass index (BMI) greater than 32\]. * Have laboratory results that do not fall in a healthy range (e.g., blood hemoglobin less than 12.0 mg/dl). * Have baseline EKG readings that are abnormal that could place the patient at the higher risk as decided by the study medical doctor (MD) * Have history of intolerance, allergic reactions (e.g. rash) or other forms of hypersensitivities to any of the study medications (dextromethorphan and bupropion). * Have current alcohol (more than 4 alcoholic drinks per day on a regular basis) or drug abuse. * Have history or current gastrointestinal (digestive) disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs * Have history or current seizures, hypertension and heart disease or any other cardiovascular disorders * Have history or current psychiatric (mental or brain) disorders (e.g., feeling sad or unhappy, loss of interest in normal activities, worried) such as depression, anxiety, or suicidality or suicide attempts. * Have significantly compromised liver and/or kidney functions. * Have participated in a research study involving intensive blood sampling or have donated blood within the past two months * Are unable or unwilling to stop taking other substances that may interfere with the metabolism of the study drugs (bupropion and dextromethorphan) two weeks prior to and during the entire study period, including prescription medications, over-the-counter medications, herbal or dietary supplements, and alternative medicines. * Are employees or students under supervision of any of the study investigators. * Cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study. * Cannot commit the time requested for this study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Indiana Clinical Research Center (ICRC)
Indianapolis, United StatesOpen Indiana Clinical Research Center (ICRC) in Google Maps