AZD8848 Single Ascending Dose Study | NCT01560234 | Trialant
NCT01560234
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Jun 6, 2016Estimated
Enrollment
47Actual
Phase
Phase 1
Conditions
Healthy
Interventions
AZD8848
Placebo
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01560234
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D0542C00001
Secondary IDs
ID
Type
Description
Link
Eudract number 2011-005986-20
Brief Title
AZD8848 Single Ascending Dose Study
Official Title
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Apr 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2012
Primary Completion Date
Jul 2014Actual
Completion Date
Jul 2014Actual
First Submitted Date
Mar 20, 2012
First Submission Date that Met QC Criteria
Mar 21, 2012
First Posted Date
Mar 22, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 30, 2015
Results First Submitted that Met QC Criteria
May 5, 2016
Results First Posted Date
Jun 6, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 5, 2016
Last Update Posted Date
Jun 6, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.
Detailed Description
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects
Conditions Module
Conditions
Healthy
Keywords
Safety
tolerability
healthy
pharmacokinetic
pharmacodynamic
inhaled
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
47Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AZD8848
Experimental
Drug: AZD8848
Placebo
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD8848
Drug
Single dose, oral inhalation (nebuliser solution)
AZD8848
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Adverse Events
Summary of number of subjects who had at least one adverse event
Screening up to Day 13
Summary for Lymphocytes Laboratory Results
Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)
Secondary Outcomes
Measure
Description
Time Frame
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)
On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Ability to produce sputum of good enough quality for assessment of biomarkers
Exclusion Criteria:
Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP > 140 mmHg, Diastolic blood pressure (DBP) > 90 mmHg, Heart rate < 40 or > 85 beats per minute)
Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848
History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)
History of asthma or allergic rhinitis
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ajay Aggarwal
AstraZeneca R&D, 35 Gatehouse Drive, MA 02451 USA
Study Director
James Ritter, BA,MA D Phil,BM BCh,MRCP,FRCP
Quintile Drug Research Unit at Guy's Hospital Quintiles Ltd 6 Newcomen Street London SE1 1YR United Kingdom
Delaney S, Biffen M, Maltby J, Bell J, Asimus S, Aggarwal A, Kraan M, Keeling D. Tolerability in man following inhalation dosing of the selective TLR7 agonist, AZD8848. BMJ Open Respir Res. 2016 Feb 23;3(1):e000113. doi: 10.1136/bmjresp-2015-000113. eCollection 2016.
There were 47 male and female subjects (6 cohorts with additional 2 cohorts) were randomized in the study.There were 6 subjects per cohort (4 subjects received AZD8848 and 2 subjects received placebo), with the exception of Cohort 3 (1.5 μg), where 3 subjects received AZD8848 and 2 subjects received placebo.
If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.