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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin; Sitagliptin Phosphate

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 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 evidence of renal insufficiency (serum creatinine ≥ 1.5 in men and ≥ 1.3 in women)

• The subject has a history of cholelithiasis or acute pancreatitis

• 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 last 6 months or has a history of alcoholism or drug/chemical/substance abuse within past 2 years 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 mm/Hg and a mean diastolic blood pressure <50 or >90, or pulse rate higher than 100 beats per min (bpm)

• The subject has a 12-lead ECG demonstrating QTcF >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 surface antigen (HGsAg)

• The subject has used prescription or non-prescription drugs within 14 days 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 been vaccinated within the last 7 days

• The subject has had any significant blood loss, donated one unit (450 mL) or 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