A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects (JSMAD)
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|ClinicalTrials.gov Identifier: NCT01096563|
Recruitment Status : Terminated (Sponsor has taken the decision to terminate further development of the compound)
First Posted : March 31, 2010
Last Update Posted : December 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: AZD9164 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|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 Start Date :||March 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD).
The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose.
|Placebo Comparator: 2||
Dry powder for inhalation via Turbuhaler, JSMAD.
- Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) [ Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study ]
- 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 [ Time Frame: PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively) ]
- To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function [ Time Frame: Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096563
|Croydon, United Kingdom|
|Principal Investigator:||Ulrike Lorch, MD MFPM FRCA||Richmond Pharmacology Limited|
|Study Director:||Carin Jorup||AstraZeneca|