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This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-1971 | Experimental | single ascending dose of 5mg, 10mg, 30mg, 90mg, 250mg, 500mg, 1000mg, 1500mg. |
|
| placebo | Placebo Comparator | placebo matching each of the DS-1971 dosages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-1971 | Drug | 6 subjects in each group will receive DS-1971. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability adverse events | determine number, type, and severity of adverse events | 20 days after dose |
| safety and tolerability physical exam | determine adverse changes in vital signs, ECG. | 20 days after dose |
| safety and tolerability laboratory blood and urine tests | determine adverse changes in laboratory safety tests of blood (biochemistry and haematology) and urine. | from day 1 through 20 days after dose |
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentration AUC | concentration in blood measured as Area under the curve (AUC) | day 4 |
| maximum blood concentration | Cmax | day 4 |
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Inclusion Criteria:
Body Mass Index (BMI) =weight[kg] / (height [m])^2
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research Ltd. | London | NW10 7EW | United Kingdom |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| placebo |
| Drug |
2 subjects in each group will receive placebo. |
|
| time of maximum blood concentration | T_max | day 4 |
| half-life of drug in body | T_1/2 | day 4 |