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

AstraZeneca1 site in 1 country47 target enrollmentMay 2012

ConditionsHealthy

InterventionsPlacebo AZD8848

DrugsAZD8848 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 47
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

July 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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

Arms & Interventions

Placebo

Intervention: Placebo

AZD8848

Intervention: AZD8848

Outcomes

Primary Outcomes

Adverse Events

Time Frame: Screening up to Day 13

Summary of number of subjects who had at least one adverse event

Summary for Lymphocytes Laboratory Results

Time Frame: Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)

Secondary Outcomes

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)(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 - Cmax (Nmol/L)(On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h)
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma(Baseline, 48 Hours)
Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum(Baseline, 24 Hours.)