Alzheimer's Disease, Blood Concentration, Healthy Volunteers, Safety, Tolerability
Conditions
Keywords
Phase 1, healthy volunteers, double-blind, placebo-controlled, AZD3839, pharmacokinetics, Alzheimer's Disease
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
Interventions
DRUGAZD3839
Single Oral Dose
DRUGAZD3839 Placebo
Single Oral Dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed