Effects of Age, Gender & Race on the Pharmacokinetics (PK)of DS-1971a

Daiichi Sankyo1 site in 1 country48 target enrollmentSeptember 2014

ConditionsHealthy

InterventionsDS-1971a

DrugsDS-1971a

Overview

Phase: Phase 1
Intervention: DS-1971a
Conditions: Healthy
Sponsor: Daiichi Sankyo
Enrollment: 48
Locations: 1
Primary Endpoint: Pharmacokinetic (PK) Profile of DS-1971a
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

November 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daiichi Sankyo

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy volunteers:
•Cohort 1: Caucasian men, aged 18-55 years
•Cohort 2: Caucasian men, 65 years and older
•Cohort 3: Japanese men, aged 18-55 years
•Cohort 4: Caucasian women, aged 18-55 years For the purpose of determining eligibility, age is calculated at the day of dose administration
•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.

Exclusion Criteria

•Clinically relevant abnormal history, physical findings, ECG findings, or laboratory values that could interfere with the objectives of the study or the safety of the subject.
•Presence of history of acute or chronic illness, including (but not limited to) liver or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body-organ dysfunction.
•Presence or history of severe adverse reaction to any medicine.
•Presence or history of malignant disease.
•Acute or chronic infectious disease, including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or C virus (HCV) infection.
•Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
•Significant illness within 4 weeks before the dose of study medication.
•Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months, or unwilling to abstain from participating in other clinical trials during the study and for 3 months after receipt of study medication.
•Participation in another clinical study with DS-1971a.
•Blood pressure (BP) and heart rate in semi-supine position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min. Subjects with Stage 1 hypertension (systolic 140-160 mmHg; diastolic 90-100 mmHg) may be enrolled provided they do not have evidence of end-organ damage, diabetes or a 10 year cardiovascular risk \>20%.

Arms & Interventions

Caucasian men, aged 18-55 years

Intervention: DS-1971a

Caucasian men, aged 65 years or older

Intervention: DS-1971a

Japanese men, aged 18-55 years

Intervention: DS-1971a

Caucasian women, aged 18-55 years

Intervention: DS-1971a

Outcomes

Primary Outcomes

Pharmacokinetic (PK) Profile of DS-1971a

Time Frame: 4 days after dose administered

PK: plasma concentrations of DS-1971a, and derived PK parameters: Cmax, tmax, tlast, t½, AUC0-inf, AUClast, %AUCextr, λz, Vz/F and CL/F.

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability(4 days after dose administered)
changes in laboratory profile as a measure of safety and tolerability(4 days after dose administered)
change in ECG profile(4 days after dose administered)