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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Pharmacokinetics of ASP015K
• Intervention / Treatment: Drug: Placebo; Drug: peficitinib

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kyushu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests	For 48 hours after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2009
• Primary Completion (Actual): March 10, 2010
• Study Completion (Actual): March 10, 2010

Study Registration Dates

• First Submitted: October 19, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: ASP015K; Ethnic difference
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Peficitinib
• Other Study ID Numbers: 015K-CL-HV03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."