Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

NCT01358383 | Completed Phase 1

• 1 other identifier: D1120C00040
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile Idiopathic Arthritis; Pharmacokinetics; VIMOVO; fasting state; Amount of VIMOVO in the blood; taken on empty stomach

Outcome Measures

Primary Outcomes (7)

• Observed maximum concentration (Cmax)

  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).

• time of maximum concentration (tmax)

  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).

• area under the concentration-time curve from zero to time of last quantifiable concentration (AUC(0-t))

  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).

• area under the concentration-time curve from zero to infinity (AUC)

  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).

• apparent terminal rate constant (λz), apparent terminal half-life (t1/2)

  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).

• apparent systemic clearance after extravascular dosing (CL/F)

  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).

• apparent volume of distribution following extravascular dosing (Vz/F) for naproxen and esomeprazole

  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 Outcomes (3)

• Incidence and severity of Adverse events during the study as a measure of safety and tolerability

  Collected from administration of VIMOVO (Visit 2 [Residential period] Day 1) until the end of the study, including follow-up

• Abnormalties in Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) as a measure of safety and tolerability

  Labs will be taken from screening to follow up visit

• Abnormalities in Vital signs as a measure of safety and tolerability

  From screening to follow up visit

Interventions

naproxen DRUG

250mg, oral dose

esomeprazole DRUG

20mg, oral dose

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Naproxen; Esomeprazole

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mark Sostek

  AstraZeneca

  STUDY DIRECTOR

• Bo Fransson

  AstraZeneca

  STUDY CHAIR

• Kelly Craven

  Quintiles Phase I Services, Overland Park, Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 23, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (1)