Clinical trial NCT03390647: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Male Participants
Official title: A Phase 1 Clinical Study of E6130 - Clinical Pharmacology Study in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Participants
Keywords: E6130
Healthy adult male participants
Phase 1
Pharmacokinetics
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 0
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 multiple oral doses of E6130 in Japanese healthy adult male participants.


Eligibility criteria: 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

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