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Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

NCT ID: NCT00690079

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

Brief Summary

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The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.

Detailed Description

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Conditions

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Chronic Pain

Keywords

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MAD Multiple ascending dose Chronic pain pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD1386

7 groups receiving a specified volume of the active component AZD1386 at different points of time.

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol\*h/L

Placebo

7 groups receiving a specified volume of placebo at different points of time

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral admin. of doses at 11 days through a 12 days period.

Interventions

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AZD1386

Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol\*h/L

Intervention Type DRUG

Placebo

Oral admin. of doses at 11 days through a 12 days period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit.
* Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg
* Clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ECG

Exclusion Criteria

* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study.
* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity.
* Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 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 R&D Södertälje SE-151 85 Södertälje, Sweden

Principal Investigators

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Rolf Karlsten

Role: STUDY_DIRECTOR

Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

Ray Chetty

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG

Locations

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Research Site

Macclesfield, Cheshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCT No. 2007-005470-31

Identifier Type: -

Identifier Source: secondary_id

D5090C00008

Identifier Type: -

Identifier Source: org_study_id