Completed
A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Compare the Pharmacokinetic Profiles of Three Different Strengths of ASP015K Extended Release Formulation With ASP015K Immediate Release Formulation and to Evaluate Food Effect on Extended Release Strengths in Healthy Volunteers
What is being tested
ASP015K ER
+ ASP015K IR
+ ASP015K ER
Drug
Who is being recruted
From 18 to 55 Years
+25 Eligibility Criteria
How is the trial designed
Phase 1
Interventional
Study Start: June 2012
Summary
Principal SponsorAstellas Pharma Global Development, Inc.
Last updated: September 1, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2012
Actual date on which the first participant was enrolled.Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose treatments with a washout period of at least 7 days separating the dosing between two consecutive treatments. Dosing conditions include both fed and fasted conditions.
Principal SponsorAstellas Pharma Global Development, Inc.
Last updated: September 1, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
10 inclusion criteria required to participate
If female, the subject is surgically sterile (with documentation provided by a healthcare professional), or is post-menopausal (defined as at least 2 years since last regular menstrual cycle and confirmatory follicle stimulating hormone (FSH) level of >= 30 U/L at screening) and the subject is not pregnant as documented by a negative serum pregnancy test at Screening and Day -1 and is not lactating
If male, the subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional) or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method during the study and until 90 days after the last dose of study drug administration
Male subject must agree to not donate sperm during the study and until 90 days after last dose of study drug administration
The subject is able to consume the FDA high fat breakfast within 30 minutes
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15 exclusion criteria prevent from participating
The subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to Screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
The subject has a history of the human immunodeficiency virus (HIV) antibody
The subject has a positive cotinine test at Screening or Day -1
The subject has a positive test for alcohol or drugs of abuse at Screening or Day -1
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
9 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalLowest per tablet dose of ASP015K Extended Release (ER) tablets under fasted conditions
Group II
Active ComparatorMedium per tablet dose ASP015K Immediate Release (IR) tablets under fasted conditions for comparison to lowest dose ER fasted conditions
Group III
ExperimentalLowest per tablet dose of ASP015K ER tablets under fed conditions
Group IV
ExperimentalMedium per tablet dose of ASP015K ER tablets under fasted conditions
Group 5
Active ComparatorMedium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to medium dose ER fasted conditions
Group 6
ExperimentalMedium per tablet dose of ASP015K ER tablets under fed conditions
Group 7
ExperimentalHighest per tablet dose of ASP015K ER tablets under fasted conditions
Group 8
Active ComparatorMedium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to highest dose ER under fasted conditions
Group 9
ExperimentalHighest dose of ASP015K ER tablets under fed conditions
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center