- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088919
A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride When Given Together to Healthy Subjects
April 15, 2010 updated by: Astellas Pharma Inc
A Phase 1, Open Label, Randomized, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride After Separate and Concomitant Administration to Healthy Adult Subjects
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and pioglitazone hydrochloride in multiple and single doses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All subjects will be enrolled at one center and confined to the unit for up to 23 days.
Subjects will be dosed in the fasting state in one of the four groups.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33014
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
- The subject's 12-lead electrocardiogram (ECG) results are normal
- The female subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control and not pregnant or lactating
- The male or female subject agrees to practice highly effective birth control from Screening until 7 days post last dose
Exclusion Criteria:
- The subject has a history or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
- The subject has any condition possibly affecting drug absorption (e.g., gastrectomy)
- The subject has history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening or the subject tests positive for alcohol or drugs of abuse
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in
- The subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or pulse rate higher than 100 beats per min (bpm)
- The subject has a 12-lead ECG demonstrating QTc >470 msec (female) or >450 msec (male)
- The subject is known positive for human immunodeficiency virus (HIV) antibody
- The subject has a positive test for tuberculosis (TB), hepatitis C antibody, or positive for hepatitis B antigen (HBsAg)
- The subject has used prescription or non-prescription drugs within 2 weeks or 5 half-lives (whichever is longer) or complementary and alternative medicines (CAM) within 14 days prior to study drug administration (excluding oral contraceptives, hormone replacement therapy [HRT], and acetaminophen)
- The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dosing Regimen 1
|
oral tablet
oral tablet
Other Names:
|
Experimental: Dosing Regimen 2
|
oral tablet
oral tablet
Other Names:
|
Experimental: Dosing Regimen 3
|
oral tablet
oral tablet
Other Names:
|
Experimental: Dosing Regimen 4
|
oral tablet
oral tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic variables assessment through analysis of blood samples
Time Frame: Day 1 and up to Day 21
|
Day 1 and up to Day 21
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacodynamic variables assessment through analysis of blood and urine samples
Time Frame: Day -1 and up to Day 17
|
Day -1 and up to Day 17
|
Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations
Time Frame: Day 1 through scheduled group check out (Day 13 and up to Day 21) or early termination
|
Day 1 through scheduled group check out (Day 13 and up to Day 21) or early termination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
March 4, 2010
First Submitted That Met QC Criteria
March 16, 2010
First Posted (Estimate)
March 18, 2010
Study Record Updates
Last Update Posted (Estimate)
April 16, 2010
Last Update Submitted That Met QC Criteria
April 15, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1941-CL-0060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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