Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD5847; Drug: Placebo to AZD5847

• Registration Number: NCT01037725
• Lead Sponsor: AstraZeneca

Brief Summary

The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-20
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Study Completion: 2010-04
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-13
• Last Update Posted: 2010-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
• Healthy male and female volunteers. Females must be of non childbearing potential

Exclusion Criteria

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
• History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD5847 oral suspension	AZD5847	Active
Placebo to AZD5847	Placebo to AZD5847	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals	Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.	Samples taken during the residential period at defined timepoints pre-dose and post-dose.
To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847	Samples taken during the residential period at defined timepoints pre-dose and post-dose

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States