A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K

NCT01387087 | Completed Phase 1

• 1 other identifier: 015K-CL-HV01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.

Conditions

Healthy Subjects; Pharmacokinetics of ASP015K

Keywords

ASP015K; Healthy subjects; Pharmacodynamics; Maximum tolerated dose

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples

  8 days

• Pharmacokinetic assessment through the analysis of blood and urine samples

  Up to Day 4

• Pharmacodynamic assessment through the analysis of blood samples

  Up to Day 4

Study Arms (12)

Group A

EXPERIMENTAL

Lowest dose, all males, fasting

Drug: ASP015K

Group B

EXPERIMENTAL

Second lowest dose, all males, fasting

Drug: ASP015K

Group C

EXPERIMENTAL

Third lowest dose, all males, fasting

Drug: ASP015K

Group D

EXPERIMENTAL

Middle dose, all males, fasting

Drug: ASP015K

Group E

EXPERIMENTAL

Third lowest dose, all females, fasting

Drug: ASP015K

Group F

EXPERIMENTAL

Third highest dose, all males, fasting then fed

Drug: ASP015K

Group G

EXPERIMENTAL

Second highest dose, all males, fasting

Drug: ASP015K

Group H

EXPERIMENTAL

Highest dose, all males, fasting

Drug: ASP015K

Group I

EXPERIMENTAL

Second highest dose, all females, fasting

Drug: ASP015K

Placebo Group A

PLACEBO COMPARATOR

all male, fasting

Drug: Placebo

Placebo Group B

PLACEBO COMPARATOR

all male, fasting then fed

Drug: Placebo

Placebo Group C

PLACEBO COMPARATOR

all female, fasting

Drug: Placebo

Interventions

ASP015K DRUG

oral

Group A; Group B; Group C; Group D; Group E; Group F; Group G; Group H; Group I

Placebo DRUG

oral

Placebo Group A; Placebo Group B; Placebo Group C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
• If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
• Subject is medically healthy, with no clinically significant abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
• Subject's fasting clinical laboratory values are within normal limits
• Subject is a non-smoker and has not used tobacco for a minimum of 3 months
• Subjects must weigh at least 45 kg and have a Body Mass Index (BMI) of 18-32 kg/m2

You may not qualify if:

• Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
• Subject has a history of the human immunodeficiency virus (HIV) antibody
• Subject has a history of severe allergic or anaphylactic reactions
• Subject has a history of chronic diarrhea
• Subject has been vaccinated within the last 60 days prior to study drug administration
• Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
• Subject has had clinically significant illness within 1 month prior to study drug administration
• Subject has a history of hemorrhoids
• Subject has a history of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse and/or illegal drugs
• Subject has had treatment with prescription medication (except hormone replacement therapy and acetaminophen), complementary and alternative medicines (CAM) within 14 days, over-the-counter products within 1 week, or alcohol, caffeine or grapefruit juice within 24 hours prior to study drug administration
• Subject has had treatment with another investigational drug or approved therapy for investigational use within 30 days or 10 half-lives, whichever is longer, prior to study drug administration or has participated in a prior group in the current study
• Subject has a history of blood donation within 30 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

peficitinib

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 4, 2011
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 4, 2011

Record last verified: 2011-06

Locations

US (2)