Clinical trial NCT01096563: A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Administration of Single and Multiple Ascending Doses for 13 Days in Healthy Male and Female Japanese Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japanese healthy volunteer
AZD9164
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg
* Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

Primary outcomes:
measure: Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
timeFrame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Secondary outcomes:
measure: To investigate the pharmacokinetics (PK) of AZD9164 following inhaled administration of single and multiple ascending doses, by assessment of the dose proportionality, the degree of accumulation and the time linearity
timeFrame: PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively)
measure: To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function
timeFrame: Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15
Other outcomes:
Locations:
city: Croydon
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Richmond Pharmacology Limited
name: Ulrike Lorch, MD MFPM FRCA
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Carin Jorup
role: STUDY_DIRECTOR
References:
citation: Jorup C, Bengtsson T, Strandgarden K, Sjobring U. Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. BMC Pulm Med. 2014 Mar 27;14:52. doi: 10.1186/1471-2466-14-52.