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This is an open label, non-randomised, single-dose, parallel-group study in 48 healthy subjects enrolled in 4 cohorts - Caucasian men, aged 18-55 years, Caucasian men, aged 65 years or older, Japanese men, aged 18-55 years, Caucasian women, aged 18-55 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caucasian men, aged 18-55 years | Experimental |
| |
| Caucasian men, aged 65 years or older | Experimental |
| |
| Japanese men, aged 18-55 years | Experimental |
| |
| Caucasian women, aged 18-55 years | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-1971a | Drug | DS-1971a is supplied as a powder or crystals and will be given as an oral suspension with Bitrex® (taste masking agent). Each subject will receive a single oral dose of 200 mg DS 1971a . |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Profile of DS-1971a | PK: plasma concentrations of DS-1971a, and derived PK parameters: Cmax, tmax, tlast, t½, AUC0-inf, AUClast, %AUCextr, λz, Vz/F and CL/F. | 4 days after dose administered |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number and severity of events will be measured and reported. | 4 days after dose administered |
| changes in laboratory profile as a measure of safety and tolerability |
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Inclusion Criteria:
Healthy volunteers:
Caucasian subjects (Cohorts 1-2 and 4) must have 4 Caucasian grandparents.
Japanese subjects (Cohort 3 only) must have 4 ethnically Japanese grandparents, have a Japanese passport, and have lived outside Japan for no longer than 5 years.
Female subjects (Cohort 4 only) must be of non-childbearing potential, as follows:
they must be post-menopausal (the last menstrual period was at least 12 months ago, and a follicle-stimulating hormone (FSH) test at screening confirms post menopausal status); or
they must be surgically sterile, that is undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation.
A BMI in the range 18-30 kg/m2, inclusive, and weighing between 50 and 100 kg at screening.
Willing to comply with all study restrictions, including the use of contraception, concomitant medication, and dietary and lifestyle restrictions.
Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
Have given written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his/her delegate.
9. Have given written consent to have his/her data entered into The Over-volunteering Prevention System (TOPS).
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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| ID | Term |
|---|---|
| C000712258 | DS-1971a |
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clinically significant changes in blood and urine will be measured and reported (haemoglobin (Hb), red blood cells (RBC), mean corpuscular volume (MCV), mean corpuscular Hb (MCH), mean corpuscular Hb concentration (MCHC), haematocrit (HCT), white blood cells (WBC) and differential, platelets, urea, creatinine, uric acid, eGFR (only at screening), total bilirubin, total protein, albumin, globulin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma GT), glucose, phosphate, cholesterol, triglycerides, potassium, sodium, calcium, chloride)
| 4 days after dose administered |
| change in ECG profile | clinically significant changes in ECG profile (such as QTc, PR interval, Ventricular rate, QRS) will be measured and reported | 4 days after dose administered |