A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Male Participants

Healthy Participants Clinical Trial

Official title:

A Phase 1 Clinical Study of E6130 - Clinical Pharmacology Study in Healthy Adult Male Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03390647
• Other study ID #: E6130-CP2
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 21, 2017
• Est. completion date: March 2019

Study information

• Verified date: July 2018
• 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 multiple oral doses of E6130 in Japanese healthy adult male participants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study.

1. Japanese or Caucasian 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 are willing and able to comply with the conditions

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study.

1. History of surgical treatment 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, electrocardiogram 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

• Healthy Participants

Intervention

Drug:
• E6130
Oral dose
• Placebo
E6130-matched placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EA Pharma Co., Ltd.

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 A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1)
Secondary	Maximum observed serum concentration (Cmax) of E6130		Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Secondary	Maximum observed serum concentration at steady state (Css, max) of E6130		Days 1 to 7 (Cohorts A2 to A4)
Secondary	Time to Cmax (tmax) of E6130		Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Secondary	Time to Cmax at steady state (tss, max) of E6130		Days 1 to 7 (Cohorts A2 to A4)
Secondary	Area under the serum concentration-time curve from zero time to the time of last quantifiable concentration (AUC[0-t]) of E6130		Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Secondary	Area under the serum concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) of E6130		Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Secondary	Area under the serum concentration-time curve from zero time to 24 hours (AUC[0-24h]) of E6130		Days 1 to 7 (Cohorts A2 to A4)
Secondary	Terminal elimination phase half-life (t1/2) of E6130		Days 1 to 7 (Cohorts A2 to A4)