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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: AZD8683
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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™

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD8683 iv
 Drug: AZD8683
Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
Experimental: 2
AZD8683 oral
 Drug: AZD8683
Solution to be administered orally Total dose of 950 µg AZD8683
Experimental: 3
AZD8683 inhalation New Dry Powder Inhaler
 Drug: AZD8683
Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
Experimental: 4
AZD8683 inhalation Turbuhaler™
 Drug: AZD8683
Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683

Detailed Description:

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™

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666613

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carin Jorup, MD AstraZeneca R&D, Molndal Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01666613     History of Changes
Other Study ID Numbers: D1883C00008, EudraCT number 2012-002901-23
Study First Received: August 14, 2012
Last Updated: December 18, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase I, Healthy volunteers, pharmacokinetics
Bioavailability
AUC

ClinicalTrials.gov processed this record on May 16, 2013