| Trial registration number
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JPRN-jRCT2031210010 |
Full text link
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCT2031210010
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First author
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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MSDJRCT inquiry mailbox
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Contact
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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msdjrct@merck.com
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Registration date
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-04-05
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Recruitment status
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy Japanese male between the ages of 20 and 60 years with BMI of 18.5 to 24.9 kg/m2
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Exclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Has a history of clinically significant abnormalities or diseases.
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Number of arms
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Tanaka Yoshiyuki
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Inclusion age min
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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Countries
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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72
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primary outcome
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Adverse events; vital signs; laboratory safety tests; 12-lead electrocardiograms; physical examinations following a single or multiple oral doses of MK-44822. Cmax; Tmax; t1/2; AUC0-12; AUC0-last and AUC0-inf of N-hydroxycytidine in plasma following a single oral dose of MK-44823. Ctrough; Cmax; Tmax; t1/2; AUC0-tau; accumulation ratio for Cmax and AUC0-tau of N-hydroxycytidine following multiple oral doses of MK-4482
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Notes
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 1
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Arms
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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