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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer; Pharmacokinetics of ASP015K

Treatments: Drug: peficitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225224

015K-CL-HV03

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 6 patient groups, including a placebo group

ASP015K Single Japanese Group

Experimental group

Description:

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

Treatment:

Drug: peficitinib

ASP015K Single Caucasian Group

Experimental group

Description:

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

Treatment:

Drug: peficitinib

Placebo Single Japanese Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Placebo Single Caucasian Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

ASP015K Multiple Group

Experimental group

Description:

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.

Treatment:

Drug: peficitinib

Placebo Multiple Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo