AZD5985 Single Ascending Dose Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00967356
Recruitment Status : Terminated (Terminated (halted prematurely) due to tolerability issues.)
First Posted : August 27, 2009
Last Update Posted : November 13, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD5985 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : August 2009
Estimated Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: A
Drug: 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

Placebo Comparator: B
Drug: Placebo
Oral suspension

Primary Outcome Measures :
  1. Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: Frequent sampling occasions during study days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00967356

Research Site
Goteborg, Sweden
Sponsors and Collaborators
Study Director: Eva Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Marianne Hartford AstraZeneca R&D, Mölndal, Sweden

Responsible Party: AstraZeneca, Christer Hultquist MSD, AstraZeneca Identifier: NCT00967356     History of Changes
Other Study ID Numbers: D2300C00002
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

Keywords provided by AstraZeneca:
Healthy volunteers