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Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

NCT00945178 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2010-12-10

No results posted yet for this study

Summary

The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AZD1386

Single ascending and multiple (twice daily) oral doses, capsule

DRUG

Placebo for AZD1386

Single ascending and multiple (twice daily) oral doses, capsule

DRUG

Naproxen

Tablet, single oral dose, 500mg

DRUG

Placebo for Naproxen

Tablet, single oral dose

Sponsors & Collaborators

Principal Investigators

  • Richard Leff · AstraZeneca Pharmaceuticals, Wilmington, UK

  • Dr. Tania Hugo · PAREXEL Early Phase Clinical Unit, London UK.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00945178 on ClinicalTrials.gov