AZD5985 Single Ascending Dose Study

This study has been terminated.
(Terminated (halted prematurely) due to tolerability issues.)
Information provided by:
AstraZeneca Identifier:
First received: August 26, 2009
Last updated: November 11, 2009
Last verified: November 2009

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 Intervention Phase
Drug: AZD5985
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: August 2009
Estimated Study Completion Date: November 2009
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: AstraZeneca, Christer Hultquist MSD, AstraZeneca Identifier: NCT00967356     History of Changes
Other Study ID Numbers: D2300C00002
Study First Received: August 26, 2009
Last Updated: November 11, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Healthy volunteers processed this record on April 16, 2014