Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Male Participants | Drug: E3112 Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects |
Actual Study Start Date : | April 22, 2019 |
Actual Primary Completion Date : | May 20, 2020 |
Actual Study Completion Date : | October 1, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Experimental: Cohort 1 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Experimental: Cohort 2 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Experimental: Cohort 2 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Experimental: Cohort 3 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Experimental: Cohort 3 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Experimental: Cohort 4 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Experimental: Cohort 4 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
|
Drug: E3112
Intravenous infusion.
Other: Placebo Intravenous infusion.
|
Ages Eligible for Study: | 20 Years to 44 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
EA Pharma Trial Site | |
Higashi, Fukuoka, Japan |
Tracking Information | |||||
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First Submitted Date ICMJE | April 16, 2019 | ||||
First Posted Date ICMJE | April 22, 2019 | ||||
Last Update Posted Date | March 15, 2021 | ||||
Actual Study Start Date ICMJE | April 22, 2019 | ||||
Actual Primary Completion Date | May 20, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants | ||||
Official Title ICMJE | A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects | ||||
Brief Summary | The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy Male Participants | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
24 | ||||
Original Estimated Enrollment ICMJE |
30 | ||||
Actual Study Completion Date ICMJE | October 1, 2020 | ||||
Actual Primary Completion Date | May 20, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 44 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03922633 | ||||
Other Study ID Numbers ICMJE | E3112-CP2 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Eisai Inc. ( EA Pharma Co., Ltd. ) | ||||
Study Sponsor ICMJE | EA Pharma Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Eisai Inc. | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |