CompletedPhase 1

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

Lead sponsor

AstraZeneca

Asset

AZD3839

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoints

•Number of Adverse Event as a measure of safety•Number of Adverse Events as a measure of Safety

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary2011-001337-16

Org study IDD4080C00001

NCT IDNCT01348737

Timeline

Milestones

Study first posted2011-05-05estimated

Study start2011-06 (month precision)

Primary completion2011-11actual (month precision)

Study completion2011-11actual (month precision)

Last update posted2012-04-06estimated

Assets

Drug assets

AZD3839

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

event count, event

Primary/protocol endpoint

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

event count, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

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)

concentration, descriptive

Secondary/protocol endpoint/low confidence

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)

concentration, descriptive

Secondary/protocol endpoint/low confidence

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)

concentration, descriptive

Secondary/protocol endpoint/low confidence

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

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.