- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967356
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
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
Keywords
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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