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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCT2051210183 |
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Date of registration:
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02/03/2022 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Single Dose Study of MK-6194 in Healthy Japanese Participants
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Scientific title:
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A Single Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-6194 in Healthy Japanese Participants |
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Date of first enrolment:
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09/03/2022 |
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Target sample size:
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48 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCT2051210183 |
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Study type:
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Interventional |
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Study design:
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randomized controlled trial, double blind, placebo control, single assignment, other
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Phase:
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1
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Contacts
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Name:
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Yoshiyuki
Tanaka |
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Address:
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KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
102-8667
Tokyo
Japan |
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Telephone:
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+81-3-6272-1957 |
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Email:
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msdjrct@merck.com |
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Affiliation:
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MSD K.K. |
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Name:
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inquiry mailbox
MSDJRCT |
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Address:
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KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
102-8667
Tokyo
Japan |
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Telephone:
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+81-3-6272-1957 |
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Email:
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msdjrct@merck.com |
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Affiliation:
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MSD K.K. |
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy Japanese male between the ages of 20 and 55 years with BMI within 18 to 25 kg/m2 inclusive and weight >=50 kg
Exclusion criteria: History of clinically significant abnormalities or diseases
Age minimum:
>= 20age old
Age maximum:
<= 55age old
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Ulcerative colitis
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Intervention(s)
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- Drug: MK-6194
MK-6194 1-7.5 mg subcutaneously administered in sterile solution form once
- Drug: Placebo
5% glucose subcutaneously administered in sterile solution form once
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Primary Outcome(s)
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Adverse events
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Secondary Outcome(s)
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- AUC0-last, AUC0-inf, Cmax, Tmax, apparent t1/2, CL/F and Vz/F
- Immunophenotyping of regulatory T cells
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Source(s) of Monetary Support
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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