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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088919
• Other study ID #: 1941-CL-0060
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2010
• Last updated: April 15, 2010
• Start date: November 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of ASP1941

Intervention

Drug:
• ASP1941
oral tablet
• pioglitazone hydrochloride
oral tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic variables assessment through analysis of blood samples		Day 1 and up to Day 21	No
Secondary	Pharmacodynamic variables assessment through analysis of blood and urine samples		Day -1 and up to Day 17	No
Secondary	Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations		Day 1 through scheduled group check out (Day 13 and up to Day 21) or early termination	No