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

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

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 May 16, 2013