NCT01635985

Brief Summary

The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

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 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

July 5, 2012

Last Update Submit

January 13, 2015

Conditions

Bioavailability and AUC

Keywords

Phase I, Healthy male volunteers, pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary

    Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.

Secondary Outcomes (4)

  • Pharmacokinetics of AZD5423 following i.v administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss

    Blood samples taken pre-dose and at 5, 10, 25, 30, 35 and 45 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48, 72 and 96 hours post dose.

  • Pharmacokinetics of AZD5423 following oral administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss

    Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36 and 48 hours post dose.

  • Pharmacokinetics of AZD5423 following oral inhalation by Spira, I-neb, Turbuhaler and New Dry Powder Inhaler in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss

    Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.

  • Safety profile in terms of adverse events, ECG, heart rate, blood pressure, pulse rate, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis.

    Screening to 28 days post dose.

Study Arms (6)

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

5

EXPERIMENTAL

AZD5423 inhalation Turbuhaler

Drug: AZD5423

6

EXPERIMENTAL

AZD5423, New Dry Powder Inhaler

Drug: AZD5423

Interventions

AZD5423DRUG

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

1

Eligibility Criteria

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

You may qualify if:

  • Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
  • Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
  • Be able to inhale from the inhaler devices used in the study according to given instructions as well as be able to perform spirometry

You may not qualify if:

  • History of any clinically significant disease or disorder
  • Current smokers
  • Any clinically relevant abnormal findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

London, UK, United Kingdom

Location

Related Links

MeSH Terms

Interventions

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

Study Officials

  • Carin Jorup, MD

    AstraZeneca R&D, Molndal Sweden

    STUDY DIRECTOR

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

July 5, 2012

First Posted

July 10, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

GB(1)