NCT01166698

Brief Summary

The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2010

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

First Submitted

Initial submission to the registry

July 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

5 months

First QC Date

July 20, 2010

Last Update Submit

November 8, 2011

Conditions

Healthy VolunteersSafetyTolerability

Keywords

Safetytolerabilityhealthyinhalation

Outcome Measures

Primary Outcomes (1)

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

    Frequent safety measurements during the study from screening period to follow-up

Secondary Outcomes (1)

  • Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma

    Multiple PK blood samples from pre-dose until 96 hours post last dose

Study Arms (2)

AZD9819

EXPERIMENTAL

Inhaled suspension

Drug: AZD9819

Placebo

PLACEBO COMPARATOR

Inhaled suspension

Drug: Placebo

Interventions

AZD9819DRUG

Inhaled single doses of suspension via SPIRA nebuliser

AZD9819
PlaceboDRUG

Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)

Also known as: Part A and B
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
  • Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

AZD9819

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 21, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

GB(1)