AZD8848 Single Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01560234
First received: March 20, 2012
Last updated: May 5, 2016
Last verified: April 2016
  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:
  • Adverse Events [ Time Frame: Screening up to Day 13 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L) [ 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 ]
  • Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L) [ 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 ]
  • Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L) [ 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 ]
  • Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma [ Time Frame: Baseline, 24 Hours. ] [ Designated as safety issue: No ]
    Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix

  • Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma [ Time Frame: Baseline, 48 Hours ] [ Designated as safety issue: No ]
    Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix

  • Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum [ Time Frame: Baseline, 24 Hours. ] [ Designated as safety issue: No ]
    Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix


Enrollment: 47
Study Start Date: May 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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 50 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ajay Aggarwal AstraZeneca R&D, 35 Gatehouse Drive, MA 02451 USA
Principal Investigator: 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
  More Information

Additional Information:
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
Results First Received: July 30, 2015
Last Updated: May 5, 2016
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 July 28, 2016