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AZD8075 Single Ascending Dose Study

NCT ID: NCT00787072

Last Updated: 2010-12-02

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-01-31

Brief Summary

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The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

Detailed Description

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Conditions

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Healthy Volunteers

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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1

Group Type EXPERIMENTAL

AZD8075

Intervention Type DRUG

Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral suspension

Interventions

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AZD8075

Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.

Intervention Type DRUG

Placebo

Oral suspension

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.
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.

Exclusion Criteria

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Lund, Sweden

Principal Investigators

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Eva Pettersson

Role: STUDY_DIRECTOR

AstraZeneca R&D, Lund, Sweden

Wolfgang Kühn

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Uppsala, Sweden

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D3801C00001

Identifier Type: -

Identifier Source: org_study_id