Clinical Trials/NCT01116258

NCT01116258

Completed

Phase 1

A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5847 Following Oral Administration to Healthy Male Subjects and Female Subjects of Non-childbearing Potential

AstraZeneca1 site in 1 country60 target enrollmentApril 2010

ConditionsHealthy

InterventionsAZD5847 Placebo

DrugsAZD5847 Placebo

Overview

Phase: Phase 1
Intervention: AZD5847
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 60
Locations: 1
Primary Endpoint: Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

October 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

Intervention: AZD5847

2

Intervention: Placebo

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(PK-sampling during 14 pre-defined study days for PK profiling)

Study Sites (1)

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