A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

AstraZeneca1 site in 1 country72 target enrollmentOctober 2008

Overview

Phase: Phase 1
Intervention: AZD8075
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Enrollment: 72
Locations: 1
Primary Endpoint: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Status: Terminated
Last Updated: 15 years ago

The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

January 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

•Provision of signed, written and dated informed consent prior to any study specific procedures.
•Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
•Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.

•Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
•Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
•Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2