NCT01310322

Brief Summary

A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2011

Typical duration 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

First Submitted

Initial submission to the registry

February 17, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

February 17, 2011

Last Update Submit

January 13, 2015

Conditions

HealthyAsthma

Keywords

Phase IHealthy male volunteersmild asthmaticspharmacokineticsBioavailability and AUCLevel of AZD5423 in your blood

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)

    Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  • Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)

    Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  • Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)

    Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  • Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).

    Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary Outcomes (2)

  • To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax

    Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  • To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.

    From screening to follow-up

Study Arms (4)

1

EXPERIMENTAL

AZD5423 iv

Drug: AZD5423

2

EXPERIMENTAL

AZD5423 inhalation, Spira

Drug: AZD5423

3

EXPERIMENTAL

AZD5423 inhalation I-neb

Drug: AZD5423

4

EXPERIMENTAL

AZD5423 oral

Drug: AZD5423

Interventions

AZD5423DRUG

solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423

1

Eligibility Criteria

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

You may qualify if:

  • Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
  • Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
  • Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
  • Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath

You may not qualify if:

  • History of any clinically significant disease or disorder
  • Any clinically relevant abnormal findings
  • Current smokers
  • Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
  • Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit

London, SE1 1YR, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

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

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Darren Wilbraham, Dr

    Quintiles Drug Research Unit at Guy's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

March 8, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

GB(1)