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

NCT01104532 | Completed Phase 1

• 1 other identifier: 1941-CL-0066
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Pharmacokinetics of ASP1941

Keywords

ASP1941; Januvia; sitagliptin

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic variables assessment through analysis of blood samples

  Day 1 to Day 15

Secondary Outcomes (2)

• 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.

Study Arms (4)

Dosing Regimen 1

EXPERIMENTAL

Drug: ASP1941; Drug: sitagliptin

Dosing Regimen 2

EXPERIMENTAL

Drug: ASP1941; Drug: sitagliptin

Dosing Regimen 3

EXPERIMENTAL

Drug: ASP1941; Drug: sitagliptin

Dosing Regimen 4

EXPERIMENTAL

Drug: ASP1941; Drug: sitagliptin

Interventions

ASP1941 DRUG

oral tablet

Dosing Regimen 1; Dosing Regimen 2; Dosing Regimen 3; Dosing Regimen 4

sitagliptin DRUG

oral tablet

Also known as: Januvia

Dosing Regimen 1; Dosing Regimen 2; Dosing Regimen 3; Dosing Regimen 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

ipragliflozin; Sitagliptin Phosphate

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 15, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 16, 2010

Record last verified: 2010-04

Locations

US (1)