| 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 | |||||
|---|---|---|---|---|---|
| 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 |
|
||||
| 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:
|
||||
| Sex/Gender ICMJE |
|
||||
| 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 |
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