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

NCT01666613 | Withdrawn Phase 1

• 2 other identifiers: D1883C00008EudraCT number 2012-002901-23
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Phase I, Healthy volunteers, pharmacokinetics; Bioavailability; AUC

Outcome Measures

Primary Outcomes (1)

• Absolute pulmonary bioavailability of AZD8683 delivered by the new dry powder inhaler in terms of: Fpulmonary

  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.

Secondary Outcomes (6)

• Absolute pulmonary bioavailability of AZD8683 delivered by the Turbuhaler™ in terms of: Fpulmonary

  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.

• 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

  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.

• Pharmacokinetics of AZD8683 following oral administration in terms of: Fpo

  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.

• 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.

  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.

• Pharmacokinetics of AZD8683 following i.v. administration in terms of: CL, Vz, and Vss

  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.

Study Arms (4)

1

EXPERIMENTAL

AZD8683 iv

Drug: AZD8683

2

EXPERIMENTAL

AZD8683 oral

Drug: AZD8683

3

EXPERIMENTAL

AZD8683 inhalation New Dry Powder Inhaler

Drug: AZD8683

4

EXPERIMENTAL

AZD8683 inhalation Turbuhaler™

Drug: AZD8683

Interventions

AZD8683 DRUG

Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of any clinically significant disease or disorder
• Current smokers
• Any clinically relevant abnormal findings in physical examination or laboratory values.

Sponsors & Collaborators

• AstraZeneca: lead

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: August 14, 2012
• First Posted: August 16, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 19, 2012

Record last verified: 2012-12