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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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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03043248 |
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Date of registration:
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02/02/2017 |
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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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TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam
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Scientific title:
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TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam in Healthy Adults |
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Date of first enrolment:
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February 6, 2017 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03043248 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Japanese healthy adult males.
- Subjects with a BMI of at least 18.0 and less than 30.0 at the screening examination
and the examination at admission.
Exclusion Criteria:
- Subjects with significant concomitant or historical disease of the metabolism, liver,
kidneys, blood, lungs, heart, digestive organs, urinary organs, or nerves, or
psychiatric diseases, accompanied by clinical symptoms or with other clinically
significant disease, who are unsuitable for participation in this study, in the
opinion of the investigators.
- Subjects who are found by the investigators to have significant clinical abnormality
at the screening examination, the examination at admission, or the examination at the
day of first administration of Digoxin or Midazolam.
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Digoxin
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Drug: Midazolam
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Drug: TRK-700
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Primary Outcome(s)
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Area under the plasma drug concentration - time curve from administration to the last available concentration measurement of Digoxin and Midazolam(AUClast)
[Time Frame: Cohort A: up to 72 hours, Cohort B: up to 48 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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