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

NCT ID: NCT00945178

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Safety Tolerability Healthy Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part A: A

AZD1386

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

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

Part A: B

Placebo for AZD1386

Group Type EXPERIMENTAL

Placebo for AZD1386

Intervention Type DRUG

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

Part B: A

Naproxen

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

Tablet, single oral dose, 500mg

Part B: B

Placebo for Naproxen

Group Type EXPERIMENTAL

Placebo for Naproxen

Intervention Type DRUG

Tablet, single oral dose

Interventions

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AZD1386

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

Intervention Type DRUG

Placebo for AZD1386

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

Intervention Type DRUG

Naproxen

Tablet, single oral dose, 500mg

Intervention Type DRUG

Placebo for Naproxen

Tablet, single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Healthy male and female (of non childbearing potential)
* Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and a weight of ≥50 to ≤100 kg

Exclusion Criteria

* History or presence of any clinically significant disease or disorder in the opinion of the investigator.
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Richard Leff

Role: STUDY_DIRECTOR

AstraZeneca Pharmaceuticals, Wilmington, UK

Dr. Tania Hugo

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Early Phase Clinical Unit, London UK.

Locations

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Research Site

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCT No.: 2009-012114-43

Identifier Type: -

Identifier Source: secondary_id

D5090C00021

Identifier Type: -

Identifier Source: org_study_id