Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01348737
First received: May 4, 2011
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

The purpose of the study is to assess the safety, tolerability and blood concentration of AZD3839 following oral administration of single doses in healthy men and women of non-childbearing potential


Condition Intervention Phase
Alzheimer's Disease
Safety
Tolerability
Blood Concentration
Healthy Volunteers
Drug: AZD3839
Drug: AZD3839 Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Biomarkers of AZD3839 Including an Open-label Food Effect Group in Healthy Male and Female Volunteers of Non-childbearing Potential

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1) [ Time Frame: Part 1 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 3) approximately 15 days ] [ Designated as safety issue: Yes ]
  • Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2) [ Time Frame: Part 2 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 4) approximately 20 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time at which maximum concentration occurs in AZD3839 (Part 1) [ Time Frame: pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3) ] [ Designated as safety issue: No ]
  • Maximum observed concentration of AZD3839 in plasma (Part 1) [ Time Frame: Part 1 - pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3) ] [ Designated as safety issue: No ]
  • Time at which maximum concentration occurs in AZD3839 (Part 2) [ Time Frame: Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the Administration. May be taken at the follow-up visit (Visit 4) ] [ Designated as safety issue: No ]
  • Maximum observed concentration of AZD3839 in plasma (Part 2) [ Time Frame: Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after administration ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD3839
Oral Treatment
Drug: AZD3839
Single Oral Dose
Placebo Comparator: AZD3839 Placebo
Oral Treatment
Drug: AZD3839 Placebo
Single Oral Dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female volunteers of non-childbearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
  • Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weigh between 50 kg and 100 kg (inclusive)
  • Creatinine clearance in the normal range (>80 mL/min estimated according to Cockroft-Gault)
  • Healthy volunteers should have a serum potassium concentration of ≥3.8 mmol/L at screening (Visit 1) and on admission to the study centre (Day -1)
  • Clinically normal findings on physical examination in relation to age, as judged by the Investigator

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study
  • History of psychotic disorder amongst first degree relatives
  • Significant orthostatic reaction at enrolment as judged by the Investigator
  • Prolonged QTcF greater than 450 msec or shortened QTcF less than 340 msec or family history of long QT syndrome or sudden death
  • Healthy volunteer is a vegetarian/lactose intolerant (exclusion criterion only applicable for healthy volunteers participating in Part 2
  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: NCT01348737

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dr Darren Wilbraham, MBBS DCPSA Quintiles Drug Research Unit at Guy's Hospital
Study Director: Dr Paul Bjornsson AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01348737     History of Changes
Other Study ID Numbers: D4080C00001, 2011-001337-16
Study First Received: May 4, 2011
Last Updated: April 5, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Phase 1
healthy volunteers
double-blind
placebo-controlled
AZD3839
pharmacokinetics
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014