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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Platelet Inhibition

Treatments: Drug: PN400; Drug: ASA; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01094483

D1120C00036

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Stable without clinically significant disease

Exclusion criteria

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

Trial design

40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

PN400 + ASA

Treatment:

Drug: ASA

Drug: PN400

2

Placebo Comparator group

Description:

Placebo + ASA

Treatment:

Drug: ASA

Drug: Placebo