A PHASE I, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO ASSESS SAFETY, TOLERABILITY AND PHARMACOKINETICS OF DS-1971A IN HEALTHY MALE SUBJECTS

Daiichi Sankyo1 site in 1 country32 target enrollmentJuly 2014

ConditionsHealthy

InterventionsDS-1971a placebo

DrugsDS-1971a placebo

Overview

Phase: Phase 1
Intervention: DS-1971a
Conditions: Healthy
Sponsor: Daiichi Sankyo
Enrollment: 32
Locations: 1
Primary Endpoint: adverse events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomised, double-blind, placebo-controlled multiple dose study designed to explore the safety, tolerability and PK of DS-1971a following oral administration over 14 days to healthy male subjects.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

November 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Daiichi Sankyo

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects aged 18-55 years.
•A body mass index (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 study and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with requirements of, the entire study.
•Have given written consent to participate in the study after reading the ICF, and after having the opportunity to discuss the study with the Investigator or his delegate.
•Have given written consent to have his data entered into The Over-volunteering Prevention System.

Exclusion Criteria

•Clinically relevant abnormal history, physical findings, ECG findings, or laboratory values that could interfere with the objectives of the study or compromise the safety of the subject.
•Presence or 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.
•History of serious 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 how the body handles or absorbs medicines.
•Significant illness within 4 weeks before the first dose of study medication.
•Participation in another clinical study 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.
•Abnormal ECG waveform morphology at screening that would preclude accurate measurement of the QT interval duration.

Arms & Interventions

DS-1971a

DS-1971a suspension, up to 4650mg/day

Intervention: DS-1971a

placebo

matching DS-1971a suspension

Intervention: placebo

Outcomes

Primary Outcomes

adverse events

Time Frame: up to 2 months

To assess the safety and tolerability of repeated oral doses of DS-1971a in healthy male subjects the number, severity, and frequency of adverse events will be recorded from enrollment through discharge from study, up to 2 months.

Secondary Outcomes

characterise the plasma pharmacokinetics Vss/F (apparent volume of distribution)(Day 1 through Day 17)
characterise the plasma pharmacokinetics Cmax (maximum concentration)(Day 1 through Day 17)
characterise the plasma pharmacokinetics CL/F (apparent oral clearance)(Day 1 through Day 17)
characterise the plasma pharmacokinetics Tmax (time of maximum concentration)(Day 1 through Day 17)
characterise the plasma pharmacokinetics T½ (terminal half-life)(Day 1 through Day 17)
characterise the plasma pharmacokinetics AUC (area under curve)(Day 1 through Day 17)