AZD5985 Single Ascending Dose Study

November 11, 2009 updated by: AstraZeneca

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD5985 in Healthy Male Subjects

The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Goteborg, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedure
  • Healthy male subjects aged 18 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 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:

  • 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
  • Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Placebo
Oral suspension
Experimental: A
AZD5985
Single dose-The starting dose will be 40 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca predefined upper exposure limits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Time Frame: Frequent sampling occasions during study days
Frequent sampling occasions during study days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic variables
Time Frame: Frequent sampling occasions during study days
Frequent sampling occasions during study days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Eva Pettersson, AstraZeneca R&D, Lund, Sweden
  • Principal Investigator: Marianne Hartford, AstraZeneca R&D, Mölndal, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

November 13, 2009

Last Update Submitted That Met QC Criteria

November 11, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • D2300C00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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