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

NCT01205867 | Completed Phase 1

• 2 other identifiers: D0540C00009EUDract No: 2010-019434-27
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Butyrylcholinesterase Deficiency

Keywords

Butyrylcholinesterase deficiency; tolerability; safety; AZD8848; pharmacokinetics; pharmacodynamics; BChE deficient subjects and matched control subject

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Repeated assessments during Day 2.

Secondary Outcomes (2)

• Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine)

  Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.

• Pharmacodynamics (IL-1Ra in plasma)

  Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.

Study Arms (1)

1

EXPERIMENTAL

AZD8848 given to BChE deficient subjects and age \& gender matched control subjects

Drug: AZD8848

Interventions

AZD8848 DRUG

Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Copenhagen, Copenhagen, Denmark

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Butyrylcholinesterase deficiency

Interventions

AZD8848

Study Officials

• Jesper Sonne, MD

  DanTrials ApS, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Sam Lindgren, MD, PhD

  AstraZeneca R&D, Lund, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 21, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

DK (1)