Text Size

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
History of Changes
  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 May 21, 2013