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AZD6088 Single Ascending Dose Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931541
First Posted: July 2, 2009
Last Update Posted: September 10, 2009
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.
Information provided by:
AstraZeneca
  Purpose
The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.

Condition Intervention Phase
Healthy Volunteers Drug: AZD6088 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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 Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp) [ Time Frame: Sampling occasions during all visits. ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Intense PK-sampling during 3 pre-defined study days for PK profiling. ]
  • Pharmacodynamics [ Time Frame: Sampling occasions during 3 pre-defined study days. ]

Enrollment: 35
Study Start Date: June 2009
Study Completion Date: August 2009
Arms Assigned Interventions
Experimental: A
AZD6088 oral solution
Drug: AZD6088
Oral solution. Each subject will receive a single-dose of AZD6088.
Experimental: B
Placebo oral solution
Drug: Placebo
Oral solution. Each subject will receive a single-dose of placebo.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
  • Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
  • Normal and suitable EEG, as judged by a neurologist

Exclusion Criteria:

  • History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
  • Any clinically important abnormalities in the ECG.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00931541


Locations
United Kingdom
Research Site
London Bridge, Greater London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Biljana Lilja AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Marianne Kasti Quintiles GDRU, London, UK
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00931541     History of Changes
Other Study ID Numbers: D0840C00007
EudraCT N0. 2008-007936-17
First Submitted: June 30, 2009
First Posted: July 2, 2009
Last Update Posted: September 10, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
Safety
Tolerability
Healthy

Additional relevant MeSH terms:
Pharmaceutical Solutions