A Study to Evaluate the Safety and Tolerability of YM150 in Healthy Caucasian and Japanese Male and Female Subjects, and to Assess the Effect That Gender May Have on Its Actions in the Body

NCT01655056 | Completed Phase 1

• 2 other identifiers: 150-CL-0062004-004935-72
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate the effect of YM150 and to compare gender and ethnic differences in healthy Caucasian and Japanese male and female subjects.

Conditions

Pharmacokinetics; Pharmacodynamics; Healthy Subjects; Caucasian; Japanese

Keywords

Pharmacokinetics; Pharmacodynamics; Phase 1; YM150; Dose-escalating; Ethnicity; Caucasian; Japanese

Outcome Measures

Primary Outcomes (1)

• Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events

  Day -21 - Day 25

Secondary Outcomes (2)

• Pharmacokinetics (PK) and pharmacodynamics (PD) of YM150 assessed by plasma and urine concentrations

  Day 1 - Day 11

• Gender effects on the PK and PD of YM150.

  Day 1 - Day 11

Study Arms (5)

low male dose

EXPERIMENTAL

Japanese and Caucasian males

Drug: YM150; Drug: Placebo

medium male dose

EXPERIMENTAL

Japanese and Caucasian males

Drug: YM150; Drug: Placebo

high male dose

EXPERIMENTAL

Japanese and Caucasian males

Drug: YM150; Drug: Placebo

high female dose

EXPERIMENTAL

Japanese and Caucasian females

Drug: YM150; Drug: Placebo

highest male dose

EXPERIMENTAL

Japanese and Caucasian males

Drug: YM150; Drug: Placebo

Interventions

YM150 DRUG

oral

Also known as: darexaban

high female dose; high male dose; highest male dose; low male dose; medium male dose

Placebo DRUG

oral

high female dose; high male dose; highest male dose; low male dose; medium male dose

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese subjects had to be born in Japan, have Japanese parents, have Japanese passports, have been resident in the West for no longer than 10 years or not at all and have a Japanese lifestyle (food habit)
• Caucasian subjects:
• Body weight:
• Males: 60-100 kg
• Females: 50-90 kg
• BMI: 18.0-27.0 kg/m2 (males and females)
• Japanese subjects:
• Body weight:
• Males: 50-80 kg
• Females: 40-70 kg
• BMI: 18.0-27.0 kg/m2 (males and females)

You may not qualify if:

• Female subject of child-bearing potential, not practicing adequate methods to prevent pregnancies, like abstinence or double barrier methods (e.g. condom in combination with a spermicidal crème)
• Female subject showing a positive pregnancy test
• Lactating mother or woman with an intention of pregnancy
• Known or suspected hypersensitivity to YM150 or any of the constituents of the formulations used
• History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums, or frequent nose bleeding
• Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)
• History of peptic ulcer or of any other organic lesion susceptible to bleed
• PT or aPTT at the screening visit outside the normal range
• Any surgical intervention (including tooth extraction) or trauma within the last 3 months preceding the initiation of the study
• Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any other drug
• Any clinically significant upper gastro-intestinal symptoms likely to interfere with the absorption of the drug
• History or presence of any cardiovascular disease or disorder
• History of a clinically significant ECG abnormality
• Any clinically relevant history of other disease or disorder - gastrointestinal, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
• Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG, and clinical laboratory tests

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

FOCUS Clinical Drug Development GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Interventions

darexaban

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: June 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: June 26, 2013

Record last verified: 2012-07

Locations

DE (1)