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Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT01348737•AstraZeneca

View on ClinicalTrials.gov

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

Age

18 - 55 years

Sex

ALL

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

Locations (1)

Research Site

London, United Kingdom

Key Dates

Start Date

June 1, 2011

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

April 6, 2012

Enrollment

ACTUAL participants

Conditions

Alzheimer's DiseaseSafetyTolerabilityBlood ConcentrationHealthy Volunteers

Interventions

AZD3839

DRUG

AZD3839 Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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