A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K - Full Text View

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

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 June 18, 2013