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

AstraZeneca

Overview

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™

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Healthy

Interventions

AZD8683DRUG

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

AZD8683DRUG

Solution to be administered orally Total dose of 950 µg AZD8683

AZD8683DRUG

Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

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.

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.

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.

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.

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

Data from ClinicalTrials.gov

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