AZD6088 Single Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00931541
First received: June 30, 2009
Last updated: September 9, 2009
Last verified: September 2009
  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
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 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Intense PK-sampling during 3 pre-defined study days for PK profiling. ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: Sampling occasions during 3 pre-defined study days. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00931541     History of Changes
Other Study ID Numbers: D0840C00007, EudraCT N0. 2008-007936-17
Study First Received: June 30, 2009
Last Updated: September 9, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
Tolerability
Healthy

ClinicalTrials.gov processed this record on April 15, 2014