A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride When Given Together to Healthy Subjects

NCT ID: NCT01088919

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

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.

Conditions

Healthy; Pharmacokinetics of ASP1941

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Dosing Regimen 1

Group Type: EXPERIMENTAL

ASP1941

Intervention Type: DRUG

oral tablet

pioglitazone hydrochloride

Intervention Type: DRUG

oral tablet

Dosing Regimen 2

Group Type: EXPERIMENTAL

ASP1941

Intervention Type: DRUG

oral tablet

pioglitazone hydrochloride

Intervention Type: DRUG

oral tablet

Dosing Regimen 3

Group Type: EXPERIMENTAL

ASP1941

Intervention Type: DRUG

oral tablet

pioglitazone hydrochloride

Intervention Type: DRUG

oral tablet

Dosing Regimen 4

Group Type: EXPERIMENTAL

ASP1941

Intervention Type: DRUG

oral tablet

pioglitazone hydrochloride

Intervention Type: DRUG

oral tablet

Interventions

ASP1941

oral tablet

Intervention Type: DRUG

pioglitazone hydrochloride

oral tablet

Intervention Type: DRUG

Other Intervention Names

Actos

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Astellas Pharma Global Development

Principal Investigators

Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Miami, Florida, United States

Countries

United States

Other Identifiers

1941-CL-0060

Identifier Type: -

Identifier Source: org_study_id