Back to resultsAssessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
naproxen
esomeprazole
Sponsored by
About this trial
This is an interventional basic science trial for Juvenile Idiopathic Arthritis focused on measuring Juvenile Idiopathic Arthritis, Pharmacokinetics, VIMOVO, fasting state, Amount of VIMOVO in the blood, taken on empty stomach
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female subjects aged 18 to 55 years
- Capable of understanding and complying with the Clinical Study Protocol
- Body mass index (BMI) of 19 to 30 kg/m2 and weight of 50 to 100 kg
Exclusion Criteria:
- Previous enrollment in the present study
- Receipt of another investigational product within 4 weeks before this study or plans to participate in another study at the same time as this study
- Female subjects with a positive urine pregnancy test
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
Observed maximum concentration (Cmax)
time of maximum concentration (tmax)
area under the concentration-time curve from zero to time of last quantifiable concentration (AUC(0-t))
area under the concentration-time curve from zero to infinity (AUC)
apparent terminal rate constant (λz), apparent terminal half-life (t1/2)
apparent systemic clearance after extravascular dosing (CL/F)
apparent volume of distribution following extravascular dosing (Vz/F) for naproxen and esomeprazole
Secondary Outcome Measures
Incidence and severity of Adverse events during the study as a measure of safety and tolerability
Abnormalties in Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) as a measure of safety and tolerability
Abnormalities in Vital signs as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01358383
Brief Title
Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers
Official Title
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.
Detailed Description
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Juvenile Idiopathic Arthritis, Pharmacokinetics, VIMOVO, fasting state, Amount of VIMOVO in the blood, taken on empty stomach
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
naproxen
Intervention Description
250mg, oral dose
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Intervention Description
20mg, oral dose
Primary Outcome Measure Information:
Title
Observed maximum concentration (Cmax)
Time Frame
Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
Title
time of maximum concentration (tmax)
Time Frame
Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
Title
area under the concentration-time curve from zero to time of last quantifiable concentration (AUC(0-t))
Time Frame
Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
Title
area under the concentration-time curve from zero to infinity (AUC)
Time Frame
Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
Title
apparent terminal rate constant (λz), apparent terminal half-life (t1/2)
Time Frame
Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
Title
apparent systemic clearance after extravascular dosing (CL/F)
Time Frame
Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
Title
apparent volume of distribution following extravascular dosing (Vz/F) for naproxen and esomeprazole
Time Frame
Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up).
Secondary Outcome Measure Information:
Title
Incidence and severity of Adverse events during the study as a measure of safety and tolerability
Time Frame
Collected from administration of VIMOVO (Visit 2 [Residential period] Day 1) until the end of the study, including follow-up
Title
Abnormalties in Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) as a measure of safety and tolerability
Time Frame
Labs will be taken from screening to follow up visit
Title
Abnormalities in Vital signs as a measure of safety and tolerability
Time Frame
From screening to follow up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and female subjects aged 18 to 55 years
Capable of understanding and complying with the Clinical Study Protocol
Body mass index (BMI) of 19 to 30 kg/m2 and weight of 50 to 100 kg
Exclusion Criteria:
Previous enrollment in the present study
Receipt of another investigational product within 4 weeks before this study or plans to participate in another study at the same time as this study
Female subjects with a positive urine pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sostek
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo Fransson
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kelly Craven
Organizational Affiliation
Quintiles Phase I Services, Overland Park, Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers
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