Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males

A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males -

A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male; Pharmacokinetics of TRK-100-STP
• Intervention / Treatment: Drug: TRK-100STP

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kyushu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body weight: =<50.0 to 80.0> kg
• BMI: =<17.6 to 26.4>
• Subjects whose condition an investigator/subinvestigator has confirmed to be healthy by the date of drug administration, based on the screening test results

Exclusion Criteria:

• Subjects who received an investigational drug within 120 days prior to the screening test in other clinical trials or post-marketing studies
• Subjects who had 400 mL whole blood drawing within 90 days prior to the screening test, who had 200 mL whole blood drawing within 30 days prior to the screening test, or had component blood drawing within 14 days prior to the screening test
• Subjects who has received or will receive any drug treatment including over the counter (OTC) drugs within 7 days prior to the day of confinement
• Subjects whose vital signs are out of the standard level in one of the following parameters at the time of the screening test or the day of confinement: blood pressure, pulse rate, body temperature, and 12-lead ECG
• Subjects who have had upper Gastro-Intestinal (GI) symptoms within 7 days prior to the day of confinement (1 day prior to the drug administration): nausea, vomiting, or stomachache
• Subjects who have complications or history of liver diseases: viral hepatitis or chronic bronchitis
• Subjects who have complications or history of Cardio Vascular (CV) diseases: chronic heart failure, angina, or arrythmia that needs treatment
• Subjects who have complications or history of respiratory diseases: severe bronchial asthma or chronic bronchitis. History of pediatric asthma is not included
• Subjects who have complications or history of respiratory diseases: severe peptic ulceration or gastro-esophageal reflux disease. History of appendicitis is not included
• Subjects who have complications or history of renal diseases: acute renal failure, glomerulonephritis, or interstitial nephritis. History of calculus is not included
• Subjects who have complications or history of cerebrovascular diseases including cerebral infarction
• Subjects who have complications or history of malignant tumors
• Subjects in whom the daily amount of alcohol or smoking is excessive
• Subjects who have received beraprost

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Japanese	Drug: TRK-100STP; oral; Other Names: beraprost; Careload LA; YM533
Experimental: Chinese	Drug: TRK-100STP; oral; Other Names: beraprost; Careload LA; YM533
Experimental: South Korean	Drug: TRK-100STP; oral; Other Names: beraprost; Careload LA; YM533

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax), area under the serum concentration-time curve (AUC) and terminal half-life (t1/2)	Up to 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests	Up to 6 days

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Toray Industries, Inc

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 24, 2011
• First Posted (Estimate): August 26, 2011

Study Record Updates

• Last Update Posted (Estimate): October 4, 2011
• Last Update Submitted That Met QC Criteria: October 2, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: PK; TRK-100STP; beraprost sodium
• Additional Relevant MeSH Terms: Vasodilator Agents; Platelet Aggregation Inhibitors; Beraprost
• Other Study ID Numbers: 533-CL-006