We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 69 for:    BUTYRYLCHOLINESTERASE
Previous Study | Return to List | Next Study

Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205867
First Posted: September 21, 2010
Last Update Posted: August 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.

Condition Intervention Phase
Butyrylcholinesterase Deficiency Drug: AZD8848 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase Deficient Subjects and to Sex and Age Matched Controls

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose [ Time Frame: Immediately prior to administration of the IP (Day 0) ]
  • Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose [ Time Frame: Repeated assessments during Day 1. ]
  • Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose [ Time Frame: Repeated assessments during Day 2. ]

Secondary Outcome Measures:
  • Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine) [ Time Frame: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h. ]
  • Pharmacodynamics (IL-1Ra in plasma) [ Time Frame: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h. ]

Enrollment: 22
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD8848 given to BChE deficient subjects and age & gender matched control subjects
Drug: AZD8848
Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg

Detailed Description:
An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test
  • Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test

Exclusion Criteria:

  • Any clinically relevant abnormal findings in physical examination, laboratory assessments, vital signs or ECG
  • Present or medical history of cardiovascular disease which, in the opinion of the investigator, may either put subject at risk because of participation in the study or influence the result of the study or the subject's ability to participate in the study
  • Family history of autoimmune disease
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01205867


Locations
Denmark
Research Site
Copenhagen, Denmark
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jesper Sonne, MD DanTrials ApS, Copenhagen, Denmark
Study Director: Sam Lindgren, MD, PhD AstraZeneca R&D, Lund, Sweden
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01205867     History of Changes
Other Study ID Numbers: D0540C00009
EUDract No: 2010-019434-27
First Submitted: September 20, 2010
First Posted: September 21, 2010
Last Update Posted: August 14, 2015
Last Verified: August 2015

Keywords provided by AstraZeneca:
Butyrylcholinesterase deficiency
tolerability
safety
AZD8848
pharmacokinetics
pharmacodynamics
BChE deficient subjects and matched control subject

Additional relevant MeSH terms:
Apnea
Metabolism, Inborn Errors
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Genetic Diseases, Inborn
Metabolic Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action