A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

Japanese Healthy Adult Male Participants Clinical Trial

Official title:

A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902978
• Other study ID #: E6130-J081-001
• Status: Completed
• Phase: Phase 1
• Start date: September 26, 2016
• Est. completion date: August 17, 2017

Study information

• Verified date: September 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.

Description:

This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind study. Cohort 8 is designed as a single-center, single dose, randomized, open-label, two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

Inclusion Criteria

1. Japanese healthy adult males aged =20 and <45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination.

2. Has voluntarily consented, in writing, to participate in this study.

3. Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

Exclusion Criteria

1. History of surgical treatment that may affect the pharmacokinetics of the study drug at screening.

2. Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, ECG findings, or laboratory values at screening or baseline.

3. History of drug allergy at screening.

4. Judged by the investigator or sub-investigator to be inappropriate for participation in this study.

Related Conditions & MeSH terms

• Japanese Healthy Adult Male Participants

Intervention

Drug:
• E6130

• Placebo
E6130 matched placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EA Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability		Days 1 to 14 (Cohort 1 to 7), Days 1 to 21 (Cohort 8)
Secondary	Maximum observed serum concentration (Cmax) of E6130		Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Secondary	Time to Cmax (Tmax) of E6130		Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Secondary	Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) of E6130		Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Secondary	Area under the serum concentration-time curve from time zero to infinity (AUC(0-inf)) of E6130		Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Secondary	Apparent terminal phase half-life (t1/2) of E6130		Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)