Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390647
Recruitment Status : Withdrawn (Decision of Sponsor)
First Posted : January 4, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( EA Pharma Co., Ltd. )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: E6130 Drug: Placebo Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1 Clinical Study of E6130 - Clinical Pharmacology Study in Healthy Adult Male Subjects
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort A1
Japanese participants will receive a single oral dose of E6130 on Day 1 and Day 7 administered in the specified order (fasted/fed or fed/fasted) to evaluate the food effect.
 Drug: E6130
Oral dose
Experimental: Cohort B1
Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1.
 Drug: E6130
Oral dose

Drug: Placebo
E6130-matched placebo
Experimental: Cohorts A2-A4
Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner.
 Drug: E6130
Oral dose

Drug: Placebo
E6130-matched placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability [ Time Frame: Days 1 to 14 (Cohort A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1) ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: EA Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03390647    
Other Study ID Numbers: E6130-CP2
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eisai Inc. ( EA Pharma Co., Ltd. ):
E6130
Healthy adult male participants
Phase 1
Pharmacokinetics