NCT01104532
Completed
Phase 1
A Phase 1, Open Label, Randomized, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP1941 and Sitagliptin After Separate and Concomitant Administration to Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- ASP1941
- Conditions
- Healthy
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 64
- Primary Endpoint
- Pharmacokinetic variables assessment through analysis of blood samples
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Detailed Description
All subjects will be enrolled at one center and confined to the unit for up to 17 days. Subjects will be dosed in the fasting state in one of the four groups.
Investigators
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 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)
Arms & Interventions
Dosing Regimen 1
Intervention: ASP1941
Dosing Regimen 1
Intervention: sitagliptin
Dosing Regimen 2
Intervention: ASP1941
Dosing Regimen 2
Intervention: sitagliptin
Dosing Regimen 3
Intervention: ASP1941
Dosing Regimen 3
Intervention: sitagliptin
Dosing Regimen 4
Intervention: ASP1941
Dosing Regimen 4
Intervention: sitagliptin
Outcomes
Primary Outcomes
Pharmacokinetic variables assessment through analysis of blood samples
Time Frame: Day 1 to Day 15
Secondary Outcomes
- Pharmacodynamic variables assessment through analysis of blood and urine samples(Day -1 and up to Day 11)
- Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations(Day 1 through scheduled group check out (Day 11 and up to Day 15) or early termination.)
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