Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)Early Phase 1NCT03420469
Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers
A Early Phase 1 study testing Bupropion in people with Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis), run by Indiana University at 1 site in United States.
Trial summary
Primary objectives: 1. To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers 2. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)
- What is being tested?
- Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2018to 1 May 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Clinical Research Center (ICRC)
Indianapolis, Indiana, 46202
About this study
Primary objectives:
- To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers
- To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.
- Being tested
- Bupropion
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Phase 1: Baseline CYP2D6 activity, using dextromethorphan (30 mg single dose PO) as a probe drug Phase 2: Single dose bupropion pharmacokinetics and its effect on CYP2D6 activity (determined by dextromethorphan 30 mg single dose PO) Phase 3: Steady state disposition of bupropion and its interaction with CYP2D6 activity (30 mg single dose PO)
| Study group | Role | What they receive |
|---|---|---|
| Baseline CYP2D6 activity | Experimental | CYP2D6 activity will be determined using a single oral dose of dextromethorphan (30 mg PO) as a probe drug at baseline (control). Receives: Drug: Bupropion |
| CYP2D6 activity with single dose of bupropion | Experimental | The effect of a single dose of bupropion (150 mg PO) on CYP2D6 activity will be determined using a single oral dose of dextromethorphan (30 mg PO) as a probe drug. Receives: Drug: Bupropion |
| CYP2D6 activity after treatment with bupropion to steady sate | Experimental | CYP2D6 activity will be determined using a single oral dose of dextromethorphan (30 mg PO) as a probe drug after 14 days pretreatment with bupropion (150 mg twice daily PO). Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure
Area under the plasma concentration versus time curves (AUC0-inf) of bupropion and its metabolites as well as CYP2D6 activity measured by dextromethorphan to dextrorphan
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start5 Jun 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is an open-label, four-phases, fixed sequence healthy volunteers study investigating: the steady state stereoselective disposition of bupropion and metabolites; and effect of multiple doses of bupropion on CYP2D6 activity, as measured by the metabolism and pharmacokinetics of a single dose of dextromethorphan
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Zeruesenay Desta, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420469
- Sponsor's protocol ID
- 1R01GM121707-01A1
- Status last verified
- Dec 2019
- First submitted
- 26 Jan 2018
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03420469
- Acronym / sponsor ID
- 1R01GM121707-01A1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objectives:
- To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers
- To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open-label, four-phases, fixed sequence healthy volunteers study investigating: the steady state stereoselective disposition of bupropion and metabolites; and effect of multiple doses of bupropion on CYP2D6 activity, as measured by the metabolism and pharmacokinetics of a single dose of dextromethorphan
| Arm | Type | Receives |
|---|---|---|
| Baseline CYP2D6 activity | Experimental | Drug: BupropionCYP2D6 activity will be determined using a single oral dose of dextromethorphan (30 mg PO) as a probe drug at baseline (control). |
| CYP2D6 activity with single dose of bupropion | Experimental | Drug: BupropionThe effect of a single dose of bupropion (150 mg PO) on CYP2D6 activity will be determined using a single oral dose of dextromethorphan (30 mg PO) as a probe drug. |
| CYP2D6 activity after treatment with bupropion to steady sate | Experimental | Drug: BupropionCYP2D6 activity will be determined using a single oral dose of dextromethorphan (30 mg PO) as a probe drug after 14 days pretreatment with bupropion (150 mg twice daily PO). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionPhase 1: Baseline CYP2D6 activity, using dextromethorphan (30 mg single dose PO) as a probe drug Phase 2: Single dose bupropion pharmacokinetics and its effect on CYP2D6 activity (determined by dextromethorphan 30 mg single dose PO) Phase 3: Steady state disposition of bupropion and its interaction with CYP2D6 activity (30 mg single dose PO) | Drug | Baseline CYP2D6 activity, CYP2D6 activity after treatment with bupropion to steady sate, CYP2D6 activity with single dose of bupropion |
Primary outcome
Exposure
Time frame: Through study completion, an average of 2 year
Area under the plasma concentration versus time curves (AUC0-inf) of bupropion and its metabolites as well as CYP2D6 activity measured by dextromethorphan to dextrorphan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bupropion in people with Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis), run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure (time frame: Through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.