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

Healthy Adult Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423435
• Other study ID #: 533-CL-006
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2011
• Last updated: October 2, 2011
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Adult Male
• Pharmacokinetics of TRK-100-STP

Intervention

Drug:
• TRK-100STP
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Toray Industries, Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests		Up to 6 days	No