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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01387087
First received: June 30, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Pharmacokinetics of ASP015K
Drug: ASP015K
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Pharmacokinetic assessment through the analysis of blood and urine samples [ Time Frame: Up to Day 4 ] [ Designated as safety issue: No ]
  • Pharmacodynamic assessment through the analysis of blood samples [ Time Frame: Up to Day 4 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: July 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387087

Locations
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
United States, Minnesota
Prism Research
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Clinical Trials Registry, Astellas Pharma Global Developmnt
ClinicalTrials.gov Identifier: NCT01387087     History of Changes
Other Study ID Numbers: 015K-CL-HV01
Study First Received: June 30, 2011
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP015K
Healthy subjects
Pharmacodynamics
Maximum tolerated dose

ClinicalTrials.gov processed this record on September 30, 2014