A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin

Platelet Inhibition Clinical Trial

Official title:

A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094483
• Other study ID #: D1120C00036
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2010
• Last updated: December 6, 2010
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stable without clinically significant disease

Exclusion Criteria:

• Use of NSAID within 2 weeks

• Type 1 or 2 DM

• GI disorder

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Platelet Inhibition

Intervention

Drug:
• PN400
naproxen 500 mg/esomeprazole 20 mg oral tablet
• ASA
Asprin 81 mg enteric coated tablet
• Placebo

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	POZEN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic: Mean percent inhibition of serum thromboxane B2		measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2	No
Primary	Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events		during approx 6 week study period	Yes