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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01104532
First received: April 14, 2010
Last updated: April 15, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Healthy
Pharmacokinetics of ASP1941
Drug: ASP1941
Drug: sitagliptin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic variables assessment through analysis of blood samples [ Time Frame: Day 1 to Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic variables assessment through analysis of blood and urine samples [ Time Frame: Day -1 and up to Day 11 ] [ Designated as safety issue: No ]
  • Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations [ Time Frame: Day 1 through scheduled group check out (Day 11 and up to Day 15) or early termination. ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing Regimen 1 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia
Experimental: Dosing Regimen 2 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia
Experimental: Dosing Regimen 3 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia
Experimental: Dosing Regimen 4 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104532

Locations
United States, Florida
Miami, Florida, United States, 33014
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Sr. Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01104532     History of Changes
Other Study ID Numbers: 1941-CL-0066
Study First Received: April 14, 2010
Last Updated: April 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP1941
Januvia
sitagliptin

Additional relevant MeSH terms:
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014