Pharmacokinetic study of GCP-002 (EP-HMRG) in healthy adult males

JRCT ID: jRCT2031200085

Registered date:17/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult male
• Date of first enrollment: 29/07/2020
• Target sample size: 6
• Study type: Interventional
• Intervention(s): A solution (20 mL) containing 50 microM of EP-HMRG is orally administered once.

Outcome(s)

• Primary Outcome: Evaluation of safety and pharmacokinetics for GCP-002(EP-HMRG) in healthy adult males

Key inclusion & exclusion criteria

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

Include criteria

1.Subjects who provide a signed document of informed consent for participation in the study
2.Subjects who are male
3.Subjects whose consent date of this trial is between 20 and 40 years old
4.Body Mass Index (BMI):18.0 kg/m2 to less than 26.0 kg/m2
5.Subjects who can be hospitalized by the date before treatment to the second day of treatment
6.Subjects who have AST, ALT, gamma-GTP, BUN, and Cre within the facility standard values for clinical test items derived from liver and kidney in the screening test
7.Subjects who can be contraceptive using condoms and other contraceptive methods for 3 months after administration of investigational products

Exclude criteria

1. Subjects current medical history or past medical history (drug addiction, alcohol addiction, drug allergy, allergic disease, heart/liver/kidney/lung/blood disease) judged to be inappropriate for participation in in this study by the Principal investigator or Sub investigator
2. Subjects positive for hepatitis B, hepatitis C, HIV test, and syphilis test
3. Subjects regular use excessive alcohol or cigarettes (who can quit drinking or quit smoking during hospitalization)
4. Subjects who received other investigational products within 3 months before the screening examination
5. Subjects to used drugs (including prescription drugs, over-the-counter drugs, herbal medicines, vitamins, dietary supplements and beverages) within 1 week before study drug administration, or plan to use drugs other than the investigational products by the end of the study
6. Subjects who blood donated 400 mL within 3 months or 200 mL within 1 month before the screening test
7. Subjects who the principal Investigator or subinvestigator considers not suitable for this trial.

Related Information

• Primary Sponsor: Maruyama Tatsuya
• Secondary ID(s): Nil known