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

NCT01423435 | Completed Phase 1

• 1 other identifier: 533-CL-006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Male; Pharmacokinetics of TRK-100-STP

Keywords

TRK-100STP; PK; beraprost sodium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests

  Up to 6 days

Study Arms (3)

Japanese

EXPERIMENTAL

Drug: TRK-100STP

Chinese

EXPERIMENTAL

Drug: TRK-100STP

South Korean

EXPERIMENTAL

Drug: TRK-100STP

Interventions

TRK-100STP DRUG

oral

Also known as: beraprost, Careload LA, YM533

Chinese; Japanese; South Korean

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Toray Industries, Inc: collaborator

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

MeSH Terms

Interventions

beraprost

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 26, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

JP (1)