NCT00847249

Brief Summary

The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

First QC Date

February 12, 2009

Last Update Submit

September 22, 2009

Conditions

Healthy

Keywords

safetytolerabilityhealthyinhalationHealthy males

Outcome Measures

Primary Outcomes (1)

  • Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)

    up to 48 hours post-dose.

Secondary Outcomes (2)

  • Pharmacokinetics

    up to 48 hours post-dose.

  • Local and extrapulmonary effects

    up to 48 hours post-dose.

Study Arms (2)

1

EXPERIMENTAL

Solution for nebulisation, inhaled

Drug: AZD9164

2

PLACEBO COMPARATOR

Solution for nebulisation, inhaled

Drug: Placebo

Interventions

AZD9164DRUG

Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

1
PlaceboDRUG

Each subject will receive a single-dose.

2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

You may not qualify if:

  • Any clinically significant disease or disorder
  • Any clinically significant abnormalities at screening examinations
  • Use of any prescribed or non-prescribed medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Lund, Sweden

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

AZD9164

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anders Luts

    AstraZeneca

    STUDY DIRECTOR

  • Ulf Malmqvist

    Clinical Trial Unit, Clinical Research and Trial Centre, Lund University Hospital, Lund, Sweden

    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

February 12, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Study Completion

April 1, 2009

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations

SE(1)