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

May 4, 2011
April 5, 2012
June 2011
November 2011   (final data collection date for primary outcome measure)
  • 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 ]
Number of Adverse Event as a measure of safety and tolerability of AZD3839 [ Time Frame: Will be collected for 15 days from admission to the study centre until the follow-up visit ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01348737 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time at which maximum concentration occurs in AZD3839 [ Time Frame: 20 Days from Visit 1 to follow-up ] [ Designated as safety issue: No ]
  • Maximum observed concentration of AZD3839 in plasma [ Time Frame: 20 Days from Visit 1 to follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Alzheimer's Disease
  • Safety
  • Tolerability
  • Blood Concentration
  • Healthy Volunteers
  • Drug: AZD3839
    Single Oral Dose
  • Drug: AZD3839 Placebo
    Single Oral Dose
  • Experimental: AZD3839
    Oral Treatment
    Intervention: Drug: AZD3839
  • Placebo Comparator: AZD3839 Placebo
    Oral Treatment
    Intervention: Drug: AZD3839 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01348737
D4080C00001, 2011-001337-16
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Dr Darren Wilbraham, MBBS DCPSA Quintiles Drug Research Unit at Guy's Hospital
Study Director: Dr Paul Bjornsson AstraZeneca
AstraZeneca
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP