Clinical trial NCT02902978: A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
Official title: A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Japanese Healthy Adult Male Participants
Keywords: E6130
Japanese healthy adult male participants
Phase 1
Pharmacokinetics
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability
timeFrame: Days 1 to 14 (Cohort 1 to 7), Days 1 to 21 (Cohort 8)
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of E6130
timeFrame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
measure: Time to Cmax (Tmax) of E6130
timeFrame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
measure: Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) of E6130
timeFrame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
measure: Area under the serum concentration-time curve from time zero to infinity (AUC(0-inf)) of E6130
timeFrame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
measure: Apparent terminal phase half-life (t1/2) of E6130
timeFrame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Other outcomes:
Locations:
city: Sumida
country: Japan
state: Tokyo
Study officials:
References: