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

NCT01225224 | Completed Phase 1

• 1 other identifier: 015K-CL-HV03
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics of ASP015K; Healthy Volunteer

Keywords

ASP015K; Ethnic difference

Outcome Measures

Primary Outcomes (1)

• Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests

  For 48 hours after administration

Secondary Outcomes (3)

• 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

Study Arms (6)

ASP015K Single Japanese Group

EXPERIMENTAL

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

Drug: peficitinib

ASP015K Single Caucasian Group

EXPERIMENTAL

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

Drug: peficitinib

Placebo Single Japanese Group

PLACEBO COMPARATOR

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

Drug: Placebo

Placebo Single Caucasian Group

PLACEBO COMPARATOR

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

Drug: Placebo

ASP015K Multiple Group

EXPERIMENTAL

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

Placebo Multiple Group

PLACEBO COMPARATOR

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

Interventions

peficitinib DRUG

oral

Also known as: ASP015K

ASP015K Multiple Group; ASP015K Single Caucasian Group; ASP015K Single Japanese Group

Placebo DRUG

oral

Placebo Multiple Group; Placebo Single Caucasian Group; Placebo Single Japanese Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

Related Publications (1)

• 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.

  PMID: 32274653 DERIVED

MeSH Terms

Interventions

peficitinib

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: November 18, 2009
• Primary Completion: March 10, 2010
• Study Completion: March 10, 2010
• Last Updated: October 16, 2024

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)