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

Phase 1

• Conditions: Esophageal cancer

• Registration Number: JPRN-jRCT2031200434
• Lead Sponsor: Maruyama Tatsuya

Brief Summary

From the results of this study, it was confirmed that the major metabolite of GCP-002 (EP-HMRG) in humans is HMRG-glucuronide conjugate, which reaches Cmax 1-2h after administration and disappears from the bloodstream by 168h after administration.The results of this study also confirmed the safety of GCP-002 (EP-HMRG) in 6 healthy adult males.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-23
• Study Completion: 2021-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 6

Inclusion 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 fourth days 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

Exclusion 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 urinary drug concentration tests (phencyclidines, benzodiazepines, cocaine narcotics, stimulants, cannabis, morphine narcotics, barbiturates, tricyclic antidepressants, etc.)
3. Subjects positive for hepatitis B, hepatitis C, HIV test, and syphilis test
4. Subjects regular use excessive alcohol or cigarettes (who can quit drinking or quit smoking during hospitalization)
5. Subjects who received other investigational products within 3 months before the screening examination
6. 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
7. Subjects who blood donated 400 mL within 3 months or 200 mL within 1 month before the screening test
8. Subjects who the principal Investigator or subinvestigator considers not suitable for this trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified