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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Oral Doses to Healthy Volunteers

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.

Study Overview

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

Detailed Description

Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.

Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.

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

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
  • Minnesota
    • St. Paul, Minnesota, United States, 55114
      • Prism Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Lowest dose, all males, fasting	Drug: ASP015K; oral
Experimental: Group B; Second lowest dose, all males, fasting	Drug: ASP015K; oral
Experimental: Group C; Third lowest dose, all males, fasting	Drug: ASP015K; oral
Experimental: Group D; Middle dose, all males, fasting	Drug: ASP015K; oral
Experimental: Group E; Third lowest dose, all females, fasting	Drug: ASP015K; oral
Experimental: Group F; Third highest dose, all males, fasting then fed	Drug: ASP015K; oral
Experimental: Group G; Second highest dose, all males, fasting	Drug: ASP015K; oral
Experimental: Group H; Highest dose, all males, fasting	Drug: ASP015K; oral
Experimental: Group I; Second highest dose, all females, fasting	Drug: ASP015K; oral
Placebo Comparator: Placebo Group A; all male, fasting	Drug: Placebo; oral
Placebo Comparator: Placebo Group B; all male, fasting then fed	Drug: Placebo; oral
Placebo Comparator: Placebo Group C; all female, fasting	Drug: Placebo; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Estimate): July 4, 2011
• Last Update Submitted That Met QC Criteria: June 30, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Healthy subjects; Maximum tolerated dose; Pharmacodynamics; ASP015K
• 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-HV01