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:
NCT01364974
First received: June 1, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

The objective of this study is to explore safety and tolerability of multiple oral doses of ASP015K in healthy volunteers.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP015K in Healthy, Non-Elderly Male and Female Adult 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: 25 days ] [ Designated as safety issue: No ]
  • Pharmacokinetic assessment through the analysis of blood and urine samples [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • Pharmacodynamic assessment through the analysis of blood samples [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
low dose, all male
Drug: ASP015K
oral
Drug: Placebo
oral
Experimental: Group B
medium dose, all male
Drug: ASP015K
oral
Drug: Placebo
oral
Experimental: Group C
high dose, all male
Drug: ASP015K
oral
Drug: Placebo
oral
Experimental: Group D
medium dose, all female
Drug: ASP015K
oral
Drug: Placebo
oral
Placebo Comparator: Placebo Drug: Placebo
oral

Detailed Description:

Subjects will be confined to the clinical research unit for 19 days. Subjects will receive a follow-up phone call to asses safety 1 to 5 days after being discharged from the study.

Subjects will receive study drug twice per day (BID) on days 1 to 13 of the 14 day treatment period, and will receive a single dose of study drug on the morning of day 14 of the treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 60 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 or a light smoker (< 10 cigarettes/day)
  • 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 is known positive for 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 positive guaiac test
  • Subject has a history of drug or alcohol abuse, a positive urine or serum screen for drugs of abuse/illegal drugs, or positive blood or breathalyzer for alcohol
  • 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: NCT01364974

Locations
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
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 Development
ClinicalTrials.gov Identifier: NCT01364974     History of Changes
Other Study ID Numbers: 015K-CL-HV02
Study First Received: June 1, 2011
Last Updated: June 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP015K
Healthy subjects

ClinicalTrials.gov processed this record on October 20, 2014