Clinical trial NCT01348737: Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Safety
Tolerability
Blood Concentration
Healthy Volunteers
Keywords: Phase 1
healthy volunteers
double-blind
placebo-controlled
AZD3839
pharmacokinetics
Alzheimer's Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1)
timeFrame: 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
measure: Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2)
timeFrame: 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:
measure: Time at which maximum concentration occurs in AZD3839 (Part 1)
timeFrame: 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)
measure: Maximum observed concentration of AZD3839 in plasma (Part 1)
timeFrame: 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)
measure: Time at which maximum concentration occurs in AZD3839 (Part 2)
timeFrame: 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)
measure: Maximum observed concentration of AZD3839 in plasma (Part 2)
timeFrame: 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
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Dr Darren Wilbraham, MBBS DCPSA
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Dr Paul Bjornsson
role: STUDY_DIRECTOR
References: