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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Pharmacokinetics of ASP1941
• Intervention / Treatment: Drug: ASP1941; Drug: sitagliptin

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing Regimen 1	Drug: ASP1941; oral tablet; Drug: sitagliptin; oral tablet; Other Names: Januvia
Experimental: Dosing Regimen 2	Drug: ASP1941; oral tablet; Drug: sitagliptin; oral tablet; Other Names: Januvia
Experimental: Dosing Regimen 3	Drug: ASP1941; oral tablet; Drug: sitagliptin; oral tablet; Other Names: Januvia
Experimental: Dosing Regimen 4	Drug: ASP1941; oral tablet; Drug: sitagliptin; oral tablet; Other Names: Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic variables assessment through analysis of blood samples	Day 1 to Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 14, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (Estimate): April 15, 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: sitagliptin; ASP1941; Januvia
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate; Ipragliflozin
• Other Study ID Numbers: 1941-CL-0066