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AZD5985 Single Ascending Dose Study

This study has been terminated.
(Terminated (halted prematurely) due to tolerability issues.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00967356
First received: August 26, 2009
Last updated: November 11, 2009
Last verified: November 2009
History of Changes
  Purpose

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
Healthy
 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
AZD5985
 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
Placebo
 Drug: Placebo
Oral suspension

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00967356

Locations
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on May 22, 2013