Methylephedrine Central and Peripheral Action Studies

JRCT ID: jRCTs031220492

Registered date:07/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy
• Date of first enrollment: 19/01/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): After taking dl-methylephedrine or placebo, peripheral nerve effects will be evaluated by cardiopulmonary exercise testing using a bicycle ergometer, and central nerve effects by PET scan using [18F] FE-PE2I, fMRI with cognitive tasks.

Outcome(s)

• Primary Outcome: Maximal oxygen uptake and exercise duration by exercise stress test

Secondary Outcome

1. DAT binding capacity in striatum, nucleus accumbens, thalamus and substantia nigra by [18F] FE-PE2I
2. Signal values of fMRI (BOLD signal)
3. Correct response rate and reaction time of cognitive tasks performed by subjects during fMRI imaging
4. The concentration of dl-methylephedrine in blood and urine, and caffeine in urine during the PET and fMRI examinations.
5. Urinary dl-methylephedrine and caffeine concentrations during exercise testing
6. Evaluation of higher brain function by neuropsychological testing
7. Evaluation of subjective mood by psychological state testing
8. Safety evaluation
The frequency and rate of occurrence of adverse events will be determined for each drug group administered. In addition, the number of adverse events and the number of cases by type and severity of adverse events will be shown. In addition, a list of each study subject (event name, date of onset, date of outcome, duration, outcome, severity, severity, and causal relationship) will be presented.

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Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) Subjects who are 20 years old or older and younger than 40 years old when obtaining consents
2) Subjects with no history of psychiatric and/or neurological disorders
3) Subjects with normal BMI (18.5 - 25)
4) Subjects without the history of smoking
5) Subjects who have the ability to provide informed consent and adhere to the protocol

Exclude criteria

Research subjects who fall into any one of the following categories will be excluded from this study
1) Subjects receiving catecholamine preparations (adrenaline, isoproterenol, etc.)
2) Subjects with a history of hypersensitivity to compounds of similar chemical structure (preparations containing ephedrine hydrochloride or methyl ephedrine hydrochloride)
3) Patients with a history of insomnia, dizziness, weakness, tremor, or irregular heartbeat caused by sympathomimetic drugs
4) Patients who have been diagnosed with any of the following diseases
(hyperthyroidism, hypertension, cardiac disease, diabetes, benign prostatic hypertrophy, renal dysfunction, disease causing urinary retention, glaucoma or other diseases causing high intraocular pressure)
5) Patients with a history of gastrointestinal symptoms upon lactose intake
6) Patients who have received drug therapy within one week prior to the scheduled date of the first dose of medication
7) Those who are scheduled to participate in the brain function test and are wearing a device (cardiac pacemaker, cerebral aneurysm clip, etc.) that is affected by the high magnetic field of the MRI machine, or have a machine or metal in their body
8) Persons who have consumed caffeine within 2 days prior to the motor function test and brain function test, or alcohol at least one day prior to the test
9) Those who have been exposed to more than 15 mSv (millisievert) per year due to radiation exposure from work or radiation therapy (15 mSv is equivalent to 3-4 x-rays of the stomach)
10) Persons who have received radiopharmaceuticals between two days prior to the PET scan and the day after the PET scan, or are scheduled to receive such contrast media or radiopharmaceuticals on the day after the PET scan.
11) Persons who wish to participate in a competition
12) Persons who do not agree to be notified of the results of the tests obtained in this study, if they are determined to be in need of treatment by the principal investigator or a physician in charge of the study.
13) Any other person who is deemed inappropriate to participate in this study by the investigator.

Related Information

• Primary Sponsor: Tateno Amane
• Source(s) of Monetary Support: Japan Anti-Doping Agency