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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01225224

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics of ASP015K Healthy Volunteer	Drug: peficitinib Drug: Placebo	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 18, 2009

Actual Primary Completion Date :

Mar 10, 2010

Actual Study Completion Date :

Mar 10, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP015K Single Japanese Group Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level.	Drug: peficitinib oral Other Names: ASP015K
Experimental: ASP015K Single Caucasian Group Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level.	Drug: peficitinib oral Other Names: ASP015K
Placebo Comparator: Placebo Single Japanese Group Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level.	Drug: Placebo oral
Placebo Comparator: Placebo Single Caucasian Group Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level.	Drug: Placebo oral
Experimental: ASP015K Multiple Group Participants will receive ASP015K in three stages, each stage corresponding to a different dosage level. ASP015K will be administered at 12-hour intervals after breakfast and dinner for seven days.	Drug: peficitinib oral Other Names: ASP015K
Placebo Comparator: Placebo Multiple Group Participants will receive placebo in three stages, each stage corresponding to a different dosage level. Placebo will be administered at 12-hour intervals after breakfast and dinner for seven days.	Drug: Placebo oral

Outcome Measures

Primary Outcome Measures

Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests [For 48 hours after administration]

Secondary Outcome Measures

Plasma unchanged drug concentration [For 48 hours after administration]
Urinary unchanged drug concentration [For 48 hours after administration]
Transcription factor phosphorylation level [For 48 hours after administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kyushu		Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair: Use Central Contact, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT01225224

Other Study ID Numbers:

015K-CL-HV03

First Posted:

Oct 20, 2010

Last Update Posted:

Sep 13, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Astellas Pharma Inc

ASP015K

Ethnic difference

Additional relevant MeSH terms:

Peficitinib

Study Results

No Results Posted as of Sep 13, 2019