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:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01104532
First received: April 14, 2010
Last updated: April 15, 2010
Last verified: April 2010
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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
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 May 21, 2013