Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects

Summary

This is a phase I, randomised, placebo-controlled 2-part study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in asthmatic and chronic obstructive pulmonary disease (COPD) subjects.

Conditions

• Asthma (Part 1)
• COPD (Part 2)

Interventions

DRUG

Dose 1, AZD8871 50 μg (Part 1)

50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 2, AZD8871 100 μg (Part 1)

100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 3, AZD8871 300 μg (Part 1)

300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 4, AZD8871 600 µg (Part 1)

600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 5, AZD8871 1200 µg (Part 1)

1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Dose 6, AZD8871 1800 μg (Part 1)

1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Placebo, AZD8871 placebo (Part 1)

AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Treatment A, AZD8871 dose A (Part 2)

AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)

DRUG

Treatment B, AZD8871 dose B (Part 2)

AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®)

DRUG

Treatment C, Indacaterol 150 μg (Part 2)

150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule

DRUG

Treatment D, Tiotropium 18 μg (Part 2)

18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Muna Albayaty, MBChB, MSc,MFPM · PAREXEL Early Phase Clinical Unit, London, United Kingdom

• Dave Singh, Prof. · The Medicines Evaluation Unit (MEU), Manchester, United Kingdom

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

130 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• United Kingdom

Study Locations