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A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD8683 When Administered in Different Ways

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01666613
First received: August 14, 2012
Last updated: December 18, 2012
Last verified: December 2012

August 14, 2012
December 18, 2012
November 2012
March 2013   (final data collection date for primary outcome measure)
Absolute pulmonary bioavailability of AZD8683 delivered by the new dry powder inhaler in terms of: Fpulmonary [ Time Frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01666613 on ClinicalTrials.gov Archive Site
  • Absolute pulmonary bioavailability of AZD8683 delivered by the Turbuhaler™ in terms of: Fpulmonary [ Time Frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD8683 following administration in terms of oral inhalation by Turbuhaler™ and New Dry Powder Inhaler in terms of: Finhalation total, FrelAUC, Frel Cmax and Foral [ Time Frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72, 96, 120 and 144 hours post dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD8683 following oral administration in terms of: Fpo [ Time Frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12 ,24, 36, and 48 hours post dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD8683 following oral administration and oral inhalation by Turbuhaler™ and New Dry Powder inhaler in terms of : AUC, AUC(0-t), Cmax, tmax, t½λz, MRT and MAT. [ Time Frame: Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72 96, 120 and 144 hours post dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD8683 following i.v. administration in terms of: CL, Vz, and Vss [ Time Frame: Blood samples taken pre-dose and at 5, 15, 20, 25 and 40 minutes and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose. ] [ Designated as safety issue: No ]
  • Safety profile in terms of adverse events, ECG, heart rate, blood pressure, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis. [ Time Frame: Screening to 4 weeks after last dose. ] [ Designated as safety issue: Yes ]
    No formal statistical tests will be performed.
Same as current
Not Provided
Not Provided
 
A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD8683 When Administered in Different Ways
A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 When Administered Inhaled Via a New Dry Powder Inhaler and Via Turbuhaler™

The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with two different devices), to healthy subjects

A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 when Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: AZD8683
    Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
  • Drug: AZD8683
    Solution to be administered orally Total dose of 950 µg AZD8683
  • Drug: AZD8683
    Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
  • Drug: AZD8683
    Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683
  • Experimental: 1
    AZD8683 iv
    Intervention: Drug: AZD8683
  • Experimental: 2
    AZD8683 oral
    Intervention: Drug: AZD8683
  • Experimental: 3
    AZD8683 inhalation New Dry Powder Inhaler
    Intervention: Drug: AZD8683
  • Experimental: 4
    AZD8683 inhalation Turbuhaler™
    Intervention: Drug: AZD8683
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males 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 weight between 50 and 100 kg (inclusive)
  • Be able to inhale from the inhaler devices used in the study.

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • Current smokers
  • Any clinically relevant abnormal findings in physical examination or laboratory values.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01666613
D1883C00008, EudraCT number 2012-002901-23
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Carin Jorup, MD AstraZeneca R&D, Molndal Sweden
AstraZeneca
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP