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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01225224
Other study ID # 015K-CL-HV03
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 18, 2009
Est. completion date March 10, 2010

Study information

Verified date September 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.


Description:

This study consists of two parts; single and multiple administration parts. In single administration part, multiple dose levels of ASP015K or placebo are administered to Japanese and Caucasian men to evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date March 10, 2010
Est. primary completion date March 10, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 44 Years
Eligibility Inclusion Criteria:

- Healthy judged by the investigator or subinvestigator on the basis of physical examination and all test results

- Weight

- Japanese: = 50.0 kg to < 80.0 kg

- Caucasians: = 50.0 kg to < 100.0 kg

- BMI

- Japanese: = 17.6 kg/m2 to < 26.4 kg/m2

- Caucasians: = 18.0 kg/m2 to < 30.0 kg/m2

- Written informed consent obtained from the subject personally

Exclusion Criteria:

- Administered drug in another clinical study or a post-market clinical study in the 120 days prior to the study

- Collection of 400 mL of whole blood within 90 days prior to the study,

200 mL of whole blood within 30 days prior to the study or blood components within 14 days prior to the study

- Received or is scheduled to receive drug treatment within 7 days prior to the drug administration

- A history of drug allergies

- Upper gastrointestinal symptoms, e.g., nausea, vomiting or stomachache, within 7 days prior to the drug admission

- Concurrent or previous liver disease, e.g., viral hepatitis or drug-induced hepatic injury

- Concurrent or previous heart disease, e.g., congestive heart failure, angina pectoris or arrhythmias requiring treatment

- Concurrent or previous kidney disease, e.g., acute renal failure,

glomerulonephritis or interstitial nephritis (except for previous urinary

calculus)

- Concurrent or previous cerebrovascular disease, e.g., cerebral infarction

- Concurrent or previous malignancy

- Concurrent or previous active or recurrent infection, e.g., hepatitis B,

hepatitis C or syphilis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
peficitinib
oral
Placebo
oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests For 48 hours after administration
Secondary Plasma unchanged drug concentration For 48 hours after administration
Secondary Urinary unchanged drug concentration For 48 hours after administration
Secondary Transcription factor phosphorylation level For 48 hours after administration
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