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OpenTrials
Completed

NCT Number: NCT00931541

AZD6088 Single Ascending Dose Study

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London Bridge, Greater London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD6088

Drug

Oral solution. Each subject will receive a single-dose of AZD6088.

Placebo

Drug

Oral solution. Each subject will receive a single-dose of placebo.

Primary outcomes

  1. Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)

    Time frame: Sampling occasions during all visits.

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Intense PK-sampling during 3 pre-defined study days for PK profiling.

  2. Pharmacodynamics

    Time frame: Sampling occasions during 3 pre-defined study days.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Jul 2, 2009
Registry last updated
Sep 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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