A Phase 1, Open Label, Randomised, Single Dose, Three Way Crossover Study to Explore the Relative Bioavailability of DS 1971a Given as a 200 mg Tablet Formulation and a 200 mg Oral Suspension, and to Explore the Effects of Administration With a High Fat Meal on the Relative Bioavailability of the Tablet Formulation

Daiichi Sankyo1 site in 1 country18 target enrollmentNovember 2014

ConditionsHealthy

InterventionsDS-1971a suspension DS-1971a tablet

DrugsDS-1971a suspension DS-1971a tablet

Overview

Phase: Phase 1
Intervention: DS-1971a suspension
Conditions: Healthy
Sponsor: Daiichi Sankyo
Enrollment: 18
Locations: 1
Primary Endpoint: Pharmacokinetics 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, 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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

January 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Daiichi Sankyo

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects aged 18 to 65 years, inclusive
•Subjects must be in good general health as determined by medical history, physical examination and screening investigations, and be taking no regular medication
•A body mass index (BMI) in the range 18 to 30 kg/m\^2, inclusive, and weighing between 50 and 100 kg. BMI is calculated as weight \[kg\]/(height \[m\])\^2
•Female subjects must be of nonchildbearing potential as follows:
•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
•Willing and able to consume a standard Food and Drug Administration (FDA) high fat meal
•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 the requirements of, the entire study
•Have given written consent to participate after reading the information and consent form, and after having the opportunity to discuss the study with the Investigator or his/her delegate
•Have given written consent to have his/her data entered into The Over-volunteering Prevention System (TOPS)

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 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
•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 study of a new chemical entity or a prescription medicine within the previous 3 months, or unwilling to abstain from participating in other clinical studies during the study and for 3 months after receipt of their final dose 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 mmHg systolic, 40-90 mmHg 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

200mg DS-1971a oral suspension fasted

200 mg DS 1971a given as oral suspension in fasted condition

Intervention: DS-1971a suspension

200 mg DS-1971a tablet fasted

single 200 mg DS 1971a oral tablet in fasted condition

Intervention: DS-1971a tablet

200 mg DS-1971a tablet fed

single 200 mg DS 1971a oral tablet given in fed condition

Intervention: DS-1971a tablet

Outcomes

Primary Outcomes

Pharmacokinetics profile of DS-1971a

Time Frame: 3 days from dose administration

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.

Secondary Outcomes

changes in clinical laboratory profile(administration of first dose to 10 weeks)
changes in physical exam profile(administration of first dose to 10 weeks)
number and severity of adverse events as a measure of safety and tolerability(administration of first dose to 10 weeks)