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

NCT ID: NCT01225224

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-18
• Study Completion Date: 2010-03-10

Brief Summary

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

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.

Conditions

Pharmacokinetics of ASP015K; Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

ASP015K Single Japanese Group

Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level.

Group Type: EXPERIMENTAL

peficitinib

Intervention Type: DRUG

oral

ASP015K Single Caucasian Group

Participants will be administered a single dose of ASP015K in three stages, each stage corresponding to a different dosage level.

Group Type: EXPERIMENTAL

peficitinib

Intervention Type: DRUG

oral

Placebo Single Japanese Group

Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Placebo Single Caucasian Group

Participants will be administered a single dose of placebo in three stages, each stage corresponding to a different dosage level.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

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.

Group Type: EXPERIMENTAL

peficitinib

Intervention Type: DRUG

oral

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Interventions

peficitinib

oral

Intervention Type: DRUG

Placebo

oral

Intervention Type: DRUG

Other Intervention Names

ASP015K

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Kyushu, , Japan

Countries

Japan

References

Shibata M, Hatta T, Saito M, Toyoshima J, Kaneko Y, Oda K, Nishimura T. Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects. Clin Drug Investig. 2020 May;40(5):469-484. doi: 10.1007/s40261-020-00910-w.

Reference Type: DERIVED

PMID: 32274653 (View on PubMed)

Other Identifiers

015K-CL-HV03

Identifier Type: -

Identifier Source: org_study_id