NCT01037504

Brief Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 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

December 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

December 20, 2009

Last Update Submit

January 13, 2015

Conditions

Healthy

Keywords

safetytolerabilityhealthyinhalationHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety variables: adverse events

    Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.

Secondary Outcomes (2)

  • Pharmacokinetics profile: concentration of AZD5423 in plasma

    Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.

  • Investigation of PD effects

    Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up.

Study Arms (2)

A

EXPERIMENTAL

Drug: AZD5423

Drug: AZD5423

B

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

AZD5423DRUG

Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

A
PlaceboDRUG

Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.

B

Eligibility Criteria

Age18 Years - 45 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
  • 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 Bridge, Greater London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Darren Wilbraham

    Quintiles Drug Research Unit at Guy's Hospital, London, UK

    PRINCIPAL INVESTIGATOR

  • Jorup Carin

    AstraZeneca R&D, Lund, Sweden

    STUDY DIRECTOR

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2009

First Posted

December 23, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

GB(1)