A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days

AstraZeneca60 enrolled

Overview

The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AZD5847DRUG

oral suspension, 15 days

PlaceboDRUG

oral suspension, 15 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI between 18-30 Exclusion Criteria: * Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes * History of presence of gastrointestinal, hepatic or renal disease

Locations (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)

Time frame: collected prior to treatment, during treatment, and follow-up for a total of 25 to 52 days(includes upto 28 days for screening)

Secondary Outcomes

characterize the Pharmacokinetics of AZD9742 in blood and urine

Time frame: PK-sampling during 14 pre-defined study days for PK profiling

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.