AZD8848 Single Ascending Dose Study - Full Text View

Purpose

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.

Condition	Intervention	Phase
Healthy	Drug: AZD8848 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Number of adverse events [ Time Frame: Screening up to Month 11 - 13 ] [ Designated as safety issue: Yes ]
Changes in baseline of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs,spirometry and physical examination findings will be presented [ Time Frame: Screening up to Day 13 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic profile for AZD8848 and AZ12432045 combined (measured as total AZ12432045) and, if possible, for AZD8848 alone after inhaled administration of AZD8848. Parameters include AUC, Cmax, tmax, lamda z, t1/2lamda z, AUC (0-t), CL/F and Vz/F [ Time Frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h ] [ Designated as safety issue: No ]
Pharmacodynamic effect of AZD8848 after inhaled administration by measuring CXCL10 concentration and change-from-baseline ratios in blood and induced sputum [ Time Frame: Between Day -5 and Day -2, at 3 timepoints on Day 1 - Day 3 and on Day 13 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	April 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD8848	Drug: AZD8848 Single dose, oral inhalation (nebuliser solution)
Placebo Comparator: Placebo	Drug: Placebo Single dose, oral inhalation (nebuliser solution)

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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560234

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: Quintiles Drug Research Unit Call Centre	0800 634 1132

Locations

United Kingdom
	Recruiting
London, UK, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Sam Lindgren, MD	AstraZeneca Research and DevelopmentSE-431 83 M lndalSweden
Principal Investigator:	Darren G Wilbraham, MBBS DCPSA	Quintile Drug Research Unit at Guy's Hospital Quintiles Ltd 6 Newcomen Street London SE1 1YR United Kingdom

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01560234 History of Changes
Other Study ID Numbers:	D0542C00001, Eudract number 2011-005986-20
Study First Received:	March 20, 2012
Last Updated:	May 8, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Safety
tolerability
healthy

pharmacokinetic
pharmacodynamic
inhaled

ClinicalTrials.gov processed this record on October 17, 2012