Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers

Healthy Volunteer Clinical Trial

Official title:

Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225224
• Other study ID #: 015K-CL-HV03
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Volunteer
• Pharmacokinetics of ASP015K

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