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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: AZD5847

Drug: Placebo to AZD5847

Study type

Interventional

Funder types

Industry

Identifiers

NCT01037725

D3430C00001

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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