Study to assess effect of device and formulation on PK with AZD1402
Research type
Research Study
Full title
A Randomized Open label, 3 period, 3 treatment, Crossover Study to Assess the Effect of Inhalation Device and Formulation on Pharmacokinetics Following a Single Inhaled Dose of AZD1402 in Healthy Subjects
IRAS ID
258764
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2018-004161-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 21 days
Research summary
This is a randomised, open-label, three-period, three-treatment, crossover clinical trial to investigate the effect of inhalation device and formulation of the study drug on the pharmacokinetics (PK) of AZD1402 after administration of a single dose to healthy male and female subjects. Females must be of non-childbearing potential. Pharmacokinetics refers to how the study medication is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). The study will also see how safe the study drug is and how well the body tolerates the study drug. In addition, the taste features of the test formulations will be evaluated.
The study will comprise a screening period, three treatment periods (in-house stay: admission on Day -1, discharge on Day 3) and a final follow-up visit, with washout periods of at least 5 days between treatments. Subjects will receive a single dose of study drug during each treatment period (Treatment A: 18 mg, nebuliser solution, InnoSpire Go device; Treatment B: 10 mg, inhalation powder, Plastiape Monodose device; Treatment C: 30 mg, inhalation powder, Plastiape Monodose device). The doses are considered safe and well tolerated. Study results will provide information that are clinically relevant to the future development program and are expected to show how doses are proportional to one another when using different devices for drug administration.
This is not a first-time-in-human study. Single and repeated doses of AZD1402 have been administered to 80 healthy subjects to date. AZD1402 demonstrated a good safety and tolerability profile. Reported adverse events (AEs) were mild or moderate with the majority fully reversible. AZD1402 is being developed as inhaled therapy for the treatment of moderate to severe persistent asthma for patients that are not controlled on standard of care therapies. The study drug belongs to a new class of therapeutics, the anticalin proteins which are modified lipocalins. Lipocalins occur naturally in the human body and if modified selectively can be used to reduce inflammation in selected disease.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0071
Date of REC Opinion
18 Jan 2019
REC opinion
Favourable Opinion