AZD7687 Multiple Ascending Dose Study

NCT ID: NCT01119352

Last Updated: 2012-01-19

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-03-31

Brief Summary

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The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects

Detailed Description

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Conditions

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Overweight Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

AZD7687

Intervention Type DRUG

Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral suspension, once daily. Totally 8 doses

Interventions

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AZD7687

Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.

Intervention Type DRUG

Placebo

Oral suspension, once daily. Totally 8 doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures
* suitable veins for cannulation or repeated venepuncture.
* Have a body mass index (BMI) between 27 and 35 kg/m2

Exclusion Criteria

* Fasting serum (S)-glucose ≥7.0 mmol/L or non-fasting S-glucose ≥11.1 mmol/L at screening.
* Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment.
* Smoking more than 7 cigarettes per week from time of consent
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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Responsibility Role SPONSOR

Principal Investigators

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Jan Eriksson

Role: STUDY_DIRECTOR

AstraZeneca

Mirjana Kucajcic

Role: STUDY_CHAIR

AstraZeneca

Darren Wilbraham

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2010-019112-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D2710C00002

Identifier Type: -

Identifier Source: org_study_id

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