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CompletedNCT03420469Updated Dec 23, 2019

Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers

An Early Phase 1 interventional study of Bupropion in Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis), sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-23.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Indiana University · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was May 2019, 7 years 6 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Primary objectives:

  1. To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers
  2. To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.
02

Conditions studied

  • Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)

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03

In context

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Browse Indiana University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (, 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

Exclusion Criteria:

Subjects will be excluded from the study if they:

  • Are underweight (weigh less than 52 kg or 114 lb) or overweight [ (BMI) greater than 32].
  • Have laboratory results that do not fall in a healthy range (e.g., blood less than 12.0 mg/dl).
  • Have baseline 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Baseline CYP2D6 activity

    CYP2D6 activity will be determined using a single oral dose of dextromethorphan (30 mg PO) as a probe drug at baseline (control).

    Drug: Bupropion

  • Experimental
    CYP2D6 activity with single dose of bupropion

    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.

    Drug: Bupropion

  • Experimental
    CYP2D6 activity after treatment with bupropion to steady sate

    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).

    Drug: Bupropion

Interventions

  • DrugBupropion

    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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, an average of 2 year

07

Study locations

1 site
  • Indiana Clinical Research Center (ICRC)
    Indianapolis, Indiana 46202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in May 2019, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 5, 2018
StartActual
Jun 5, 2018
Primary completionActual
May 1, 2019
CompletionActual
May 1, 2019
Last update
Dec 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03420469
Lead sponsor
Indiana University
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Zeruesenay Desta (Professor of Medicine, Pharmacology and Toxicology, Indiana University) — Principal investigator
First posted
Feb 5, 2018
Start date
Jun 5, 2018
Primary completion
May 1, 2019
Completion
May 1, 2019
Last update
Dec 23, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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