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

NCT01348737 | Completed Phase 1

• 2 other identifiers: D4080C000012011-001337-16
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease; Safety; Tolerability; Blood Concentration; Healthy Volunteers

Keywords

Phase 1; healthy volunteers; double-blind; placebo-controlled; AZD3839; pharmacokinetics; Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1)

  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

• Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2)

  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

Secondary Outcomes (4)

• Time at which maximum concentration occurs in AZD3839 (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)

• Maximum observed concentration of AZD3839 in plasma (Part 1)

  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)

• Time at which maximum concentration occurs in AZD3839 (Part 2)

  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)

• Maximum observed concentration of AZD3839 in plasma (Part 2)

  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

Study Arms (2)

AZD3839

EXPERIMENTAL

Oral Treatment

Drug: AZD3839

AZD3839 Placebo

PLACEBO COMPARATOR

Oral Treatment

Drug: AZD3839 Placebo

Interventions

AZD3839 DRUG

Single Oral Dose

AZD3839

AZD3839 Placebo DRUG

Single Oral Dose

AZD3839 Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

AZD3839

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dr Darren Wilbraham, MBBS DCPSA

  Quintiles Drug Research Unit at Guy's Hospital

  PRINCIPAL INVESTIGATOR

• Dr Paul Bjornsson

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

GB (1)