Methamphetamine Metabolism, CYP2D6 GenotypePhase 4NCT01529892
The Impact of Genetic Variation in CYP2D6 on the Pharmacokinetics and Pharmacodynamics of Methamphetamine
A Phase 4 study testing A single oral 5 mg of duterium labeled methamphetamine in people with Methamphetamine Metabolism, CYP2D6 Genotype, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
Methamphetamine abuse and addiction are widespread and is causing increasing pressures on social, public health and criminal justice systems worldwide. Some of the risk for developing addiction may be genetic. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Metabolism, CYP2D6 Genotype
- What is being tested?
- A single oral 5 mg of duterium labeled methamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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
- The subject is healthy, as judged by a responsible physician, with no clinically significant abnormality identified on the laboratory or medical evaluation, including 12-lead ECG, at screening. A subject with a clinical laboratory or laboratory parameter outside the reference range (adjusted for age, if appropriate), may be included only if the Investigator considers that the abnormal finding does not pose additional risk and will not interfere with the study procedures.
- Male or female, aged 18-55 years inclusive
- Body weight over 50kg (110 lbs) and body mass index (BMI) of 18.5 to 30 kg/m2 inclusive.
- Have normal cardiac function including normal blood pressure and heart rate.
- Have normal renal function as evident by a creatinine clearance >70 ml/min and normal serum creatinine levels
- The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- A positive urine test for drugs of abuse or alcohol at screening or prior to the start of dosing.
- Subjects with a clinical history of current alcohol or illicit drug use which, in the opinion of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
- Active Psychiatric disease: DSM-IV diagnosis of a current alcohol, opiate, or sedative hypnotic dependence disorder requiring medical detoxification, history of decompensated schizophrenia, schizophreniform, or schizoaffective disorder; Severe mania, hypomania, agitated behaviour, bipolar disorder or post-traumatic stress disorder within the past 90 days; presence of suicidal behavior two years prior to enrolment or suicidal intent within the past 30 days.
- The subject has received an investigational drug or participated in any other research trial within 30 days, 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Use of any prescription or non-prescription drugs, vitamins, herbal and dietary supplements within seven days (or 14 days if the drug is a potential CYP2D6 enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study mediation, unless, in the opinion of the Investigator and sponsor, the medication will not interfere with the study procedures or compromise subject safety.
- Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Examples of conditions that could interfere with normal gastrointestinal anatomy or motility include gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, intestinal or urinary obstruction, or celiac sprue.
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- History of hypersensitivity to amphetamine-type drugs, or history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- Pregnancy or fertile women without adequate means of contraception.
- Any other medical or psychosocial condition that would preclude useful, safe or consistent participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke Hospital, Californai Pacific Medical Center
San Francisco, California, 94100
About this study
Official title: An Open-Label Study to Evaluate the Impact of Genetic Variation in CYP2D6 on the Pharmacokinetics and Pharmacodynamics of Methamphetamine in Healthy Adults
Methamphetamine abuse and addiction are widespread and is causing increasing pressures on social, public health and criminal justice systems worldwide. Some of the risk for developing addiction may be genetic. Identifying specific genotypes and understanding their interactions with the environment may help predict who is at risk for developing a disease. In this study the investigators are evaluating the contribution of differences in one genotype - called CYP2D6 to the removal of methamphetamine from the body. Methamphetamine is removed from the body by special enzymes in the liver. One of these enzymes is called Cytochrome P450 2D6. The activity of 2D6 is genetically determined. Some people have no active 2D6 whereas in others 2D6 is very active. One group of scientists found that people with low 2D6 activity were less likely to become methamphetamine addicts. In this study the investigators will determine the activity of your 2D6 by looking at the CYP2D6 genotype. If low levels of 2D6 decrease the risk of methamphetamine addiction it may be because there is less of the chemicals (called metabolites) made by 2D6. The first step in the metabolism (the process of removal of drugs from the body) of methamphetamine by 2D6 is conversion of methamphetamine to amphetamine and para-hydroxymethamphetamine. 2D6 then converts these to inactive chemicals. In addition to determining your genotype, the investigators are interested in the relationship of genotype with the methamphetamine metabolism. Thus, as part of this study, you will be given a modest oral dose of 5 milligrams of methamphetamine. After receiving the methamphetamine you will need to collect your urine for 24 hours.
The purpose of this study is to investigate the impact of genetic variation in CYP2D6 on the disposition of methamphetamine in the human body as well as its pharmacologic effects to humans.
- Being tested
- A single oral 5 mg of duterium labeled methamphetamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single oral 5 mg of duterium labeled methamphetamineDrug
| Study group | Role | What they receive |
|---|---|---|
| methamphetamine EM | Experimental | Extensive metabolizer will be give a single oral 5 mg of duterium labeled methamphetamine Receives: Drug: A single oral 5 mg of duterium labeled methamphetamine |
| methamphetamine PM | Experimental | Poor Metabolizers will be give a single oral 5 mg of duterium labeled methamphetamine Receives: Drug: A single oral 5 mg of duterium labeled methamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine metabolic ratio
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Metabolism, CYP2D6 GenotypeStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- Responsible party
- Principal investigator, John Mendelson, MD, California Pacific Medical Center Research Institute
- Investigators
- John Mendelson, MD, Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529892
- Sponsor's protocol ID
- 1I
- Status last verified
- May 2013
- First submitted
- 7 Feb 2012
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Impact of Genetic Variation in CYP2D6 on the Pharmacokinetics and Pharmacodynamics of Methamphetamine in Healthy Adults
- ClinicalTrials.gov ID
- NCT01529892
- Acronym / sponsor ID
- 1I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- First posted
- 9 Feb 2012 (estimated)
- 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.
Methamphetamine abuse and addiction are widespread and is causing increasing pressures on social, public health and criminal justice systems worldwide. Some of the risk for developing addiction may be genetic. Identifying specific genotypes and understanding their interactions with the environment may help predict who is at risk for developing a disease. In this study the investigators are evaluating the contribution of differences in one genotype - called CYP2D6 to the removal of methamphetamine from the body. Methamphetamine is removed from the body by special enzymes in the liver. One of these enzymes is called Cytochrome P450 2D6. The activity of 2D6 is genetically determined. Some people have no active 2D6 whereas in others 2D6 is very active. One group of scientists found that people with low 2D6 activity were less likely to become methamphetamine addicts. In this study the investigators will determine the activity of your 2D6 by looking at the CYP2D6 genotype. If low levels of 2D6 decrease the risk of methamphetamine addiction it may be because there is less of the chemicals (called metabolites) made by 2D6. The first step in the metabolism (the process of removal of drugs from the body) of methamphetamine by 2D6 is conversion of methamphetamine to amphetamine and para-hydroxymethamphetamine. 2D6 then converts these to inactive chemicals. In addition to determining your genotype, the investigators are interested in the relationship of genotype with the methamphetamine metabolism. Thus, as part of this study, you will be given a modest oral dose of 5 milligrams of methamphetamine. After receiving the methamphetamine you will need to collect your urine for 24 hours.
The purpose of this study is to investigate the impact of genetic variation in CYP2D6 on the disposition of methamphetamine in the human body as well as its pharmacologic effects to humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methamphetamine EM | Experimental | Drug: A single oral 5 mg of duterium labeled methamphetamineExtensive metabolizer will be give a single oral 5 mg of duterium labeled methamphetamine |
| methamphetamine PM | Experimental | Drug: A single oral 5 mg of duterium labeled methamphetaminePoor Metabolizers will be give a single oral 5 mg of duterium labeled methamphetamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject is healthy, as judged by a responsible physician, with no clinically significant abnormality identified on the laboratory or medical evaluation, including 12-lead ECG, at screening. A subject with a clinical laboratory or laboratory parameter outside the reference range (adjusted for age, if appropriate), may be included only if the Investigator considers that the abnormal finding does not pose additional risk and will not interfere with the study procedures.
- Male or female, aged 18-55 years inclusive
- Body weight over 50kg (110 lbs) and body mass index (BMI) of 18.5 to 30 kg/m2 inclusive.
- Have normal cardiac function including normal blood pressure and heart rate.
- Have normal renal function as evident by a creatinine clearance >70 ml/min and normal serum creatinine levels
Key exclusion criteria (9 listed)
- A positive urine test for drugs of abuse or alcohol at screening or prior to the start of dosing.
- Subjects with a clinical history of current alcohol or illicit drug use which, in the opinion of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
- Active Psychiatric disease: DSM-IV diagnosis of a current alcohol, opiate, or sedative hypnotic dependence disorder requiring medical detoxification, history of decompensated schizophrenia, schizophreniform, or schizoaffective disorder; Severe mania, hypomania, agitated behaviour, bipolar disorder or post-traumatic stress disorder within the past 90 days; presence of suicidal behavior two years prior to enrolment or suicidal intent within the past 30 days.
- The subject has received an investigational drug or participated in any other research trial within 30 days, 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Use of any prescription or non-prescription drugs, vitamins, herbal and dietary supplements within seven days (or 14 days if the drug is a potential CYP2D6 enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study mediation, unless, in the opinion of the Investigator and sponsor, the medication will not interfere with the study procedures or compromise subject safety.
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 |
|---|---|---|
| A single oral 5 mg of duterium labeled methamphetamine | Drug | methamphetamine EM, methamphetamine PM |
Primary outcome
urine metabolic ratio
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
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.
John Mendelson, MD principal investigator
California Pacific Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A single oral 5 mg of duterium labeled methamphetamine in people with Methamphetamine Metabolism, CYP2D6 Genotype, run by California Pacific Medical Center Research Institute 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 31 May 2013. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
urine metabolic ratio (time frame: 24 hours). 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 31 May 2013.