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 AZD5985 in Healthy Male Subjects

AstraZeneca1 site in 1 country72 target enrollmentAugust 2009

ConditionsHealthy

InterventionsAZD5985 Placebo

DrugsAZD5985 Placebo

Overview

Phase: Phase 1
Intervention: AZD5985
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 72
Locations: 1
Primary Endpoint: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

November 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Provision of signed, written and dated informed consent prior to any study specific procedure
•Healthy male subjects aged 18 to 45 years (inclusive)
•Have a body mass index (BMI) between 18 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

Exclusion Criteria

•History or presence of any clinically significant disease or disorder in the opinion of the investigator
•Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
•Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2