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This is a randomised, double-blind, placebo-controlled multiple ascending single study. It is hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week treatment period and will result in increases in reticulocyte count and haemoglobin concentrations in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-1093 | Experimental | Group 1 will receive 10mg, group 2 will receive 25mg of DS-1093 |
|
| placebo | Placebo Comparator | placebo to match DS-1093 dosage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-1093 | Drug | DS-1093 in capsules with 2.5mg or 25mg per capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| blood concentration of DS-1093 | level of DS-1093 will be determined in participants blood from the time of initial dosing through 15 days after. | time of dosing through Day 15 |
| number of adverse events including type and severity | number, type and severity of adverse events will be reported during the study from initial randomization through Day 98 | date of randomization through Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| levels of EPO | Pharmacodynamic (PD) analyses will be conducted for EPO (Erythropoietin ) through 42 days after initial dosing | time of dosing through 42 days after dosing |
| levels of VEGF | Pharmacodynamic (PD) analyses will be conducted forVEGF (Vascular Endothelial Growth Factor) through 42 days of dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research Ltd | London | 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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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| placebo |
| Drug |
matching placebo capsules to DS-1093 capsules |
|
| time of dosing through 42 days after dosing |
| levels of H25 | Pharmacodynamic (PD) analyses will be conducted for H25 (Hepcidin-25); through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of Reticulocytes | Pharmacodynamic (PD) analyses will be conducted for hematology markers {RET (Reticulocytes), through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of Haemoglobin | Pharmacodynamic (PD) analyses will be conducted for hematology markers Hb (haemoglobin), through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of Haematocrit | Pharmacodynamic (PD) analyses will be conducted for hematology markers HCT (haematocrit), through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of Red Blood Cells | Pharmacodynamic (PD) analyses will be conducted for hematology marker RBC (red blood cells) through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of Serum Iron | Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker {SI (Serum Iron) through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of Transferrin | Pharmacodynamic (PD) analyses will be conducted for iron metabolism markers T (Transferrin), through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of TSAT | Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker TSAT(Saturated Transferrin) through 42 days of dosing. | time of dosing through 42 days after dosing |
| levels of Ferrin | Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker F (Ferritin) through 42 days of dosing. | time of dosing through 42 days after dosing |