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

Phase 1

Completed

• Conditions: Platelet Inhibition
• Interventions: Drug: PN400; Drug: ASA; Drug: Placebo

• Registration Number: NCT01094483
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Stable without clinically significant disease

Exclusion Criteria

• Use of NSAID within 2 weeks
• Type 1 or 2 DM
• GI disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PN400	PN400 + ASA
2	Placebo	Placebo + ASA
2	ASA	Placebo + ASA
1	ASA	PN400 + ASA

Primary Outcome Measures

Name	Time	Method
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
Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events	during approx 6 week study period

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States