Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open label, randomised, 3 treatment, 3 period crossover study. This study is designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a reconstituted oral suspension and the effect of a high fat meal on the relative bioavailability of DS 1971a from the tablet formulation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200mg DS-1971a oral suspension fasted | Experimental | 200 mg DS 1971a given as oral suspension in fasted condition |
|
| 200 mg DS-1971a tablet fasted | Experimental | single 200 mg DS 1971a oral tablet in fasted condition |
|
| 200 mg DS-1971a tablet fed | Experimental | single 200 mg DS 1971a oral tablet given in fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-1971a suspension | Drug | DS 1971a will be supplied as a powder or crystals and prepared at the study site for administration as an oral suspension with a taste masking agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile of DS-1971a | Plasma concentration time data will be analysed using non compartmental methods. The following PK parameters will be estimated: Cmax, Tmax and AUClast. If data permit, AUC0-inf, CL/F, Vd/F and T½ will be estimated. | 3 days from dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| number and severity of adverse events as a measure of safety and tolerability | number and severity of adverse events as a measure of safety and tolerability | administration of first dose to 10 weeks |
| changes in clinical laboratory profile |
Not provided
Inclusion Criteria:
Must be postmenopausal (the last menstrual period was at least 12 months before Screening, and a follicle stimulating hormone [FSH] test at Screening confirms postmenopausal status); or Must be surgically sterile having undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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.
Not provided
| ID | Term |
|---|---|
| C000712258 | DS-1971a |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DS-1971a tablet | Drug | A 200 mg DS 1971a tablet for oral administration |
|
haematology, biochemistry, and urinalysis
| administration of first dose to 10 weeks |
| changes in physical exam profile | Physical examination profile includes; Height and weight, heart rate, blood pressure (BP), oral temperature and respiration rate, 12 lead electrocardiogram (ECG) | administration of first dose to 10 weeks |