NCT00931541

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

First QC Date

June 30, 2009

Last Update Submit

September 9, 2009

Conditions

Healthy Volunteers

Keywords

SafetyTolerabilityHealthy

Outcome Measures

Primary Outcomes (1)

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

    Sampling occasions during all visits.

Secondary Outcomes (2)

  • Pharmacokinetics

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

  • Pharmacodynamics

    Sampling occasions during 3 pre-defined study days.

Study Arms (2)

A

EXPERIMENTAL

AZD6088 oral solution

Drug: AZD6088

B

EXPERIMENTAL

Placebo oral solution

Drug: Placebo

Interventions

AZD6088DRUG

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

A
PlaceboDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London Bridge, Greater London, United Kingdom

Location

MeSH Terms

Interventions

AZD6088

Study Officials

  • Biljana Lilja

    AstraZeneca R&D, Södertälje, Sweden

    STUDY DIRECTOR

  • Marianne Kasti

    Quintiles GDRU, London, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

June 1, 2009

Study Completion

August 1, 2009

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

GB(1)