Phase 1 study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of AJM300 in healthy male subjects - randomised, double-blind, controlled trial

Phase 1

Completed

• Conditions: Healthy Adult Subjects

• Registration Number: JPRN-jRCT2080224930
• Lead Sponsor: EA Pharma Co., Ltd.

Brief Summary

AJM300 was of no safety concern at single doses of 40 to 320 mg in healthy male adult subjects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-05-31
• Study Start: 2019-10-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

Main inclusion criteria
- Japanese healthy male adults aged 20 or older to 55 and under, when consented.
- BMI: 18.5 to under 25.0 kg/m2
- No clinical concerns in the examinations and physiological and clinical laboratory tests at screening.
Subjects with laboratory values deviating from the center's standards that the investigator or a subinvestigator judged to be eligible to participate.
- Subjects who could consented in writing

Exclusion Criteria

Main exclusion criteria
- Subjects with past history of diseases which are likely to seriously affect absorption, distribution, metabolism, and excretion of the investigational product or surgical history of digestive or biliary tract
- Subjects complicated by gastrointestinal disease
- Subjects with past history of drug allergy
- Smoking subjects or subjects who stopped smoking within 3 months
- Subjects with past history of drug or alcohol dependence or present illness
- Subjects positive for HBs antigen, anti-HCV antibody, and anti-HIV-1 and -2 antibody, or positive in the serologic test for syphilis
- Subjects using other prescription drugs within 28 days or using OTC drugs or vitamins within 3 days before treatment with the investigational product

Study & Design

• Study Type: Interventional
• Study Design: Not specified