A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral AZD1979 After Single-ascending Doses in Healthy Male Volunteers

AstraZeneca1 site in 1 country116 target enrollmentMarch 2014

ConditionsHealthy Subjects

InterventionsAZD1979 Placebo to match

DrugsAZD1979 Placebo to match

Overview

Phase: Phase 1
Intervention: AZD1979
Conditions: Healthy Subjects
Sponsor: AstraZeneca
Enrollment: 116
Locations: 1
Primary Endpoint: Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers. Pharmacokinetics (what the body does to the drug) parameters will also be assessed as secondary objectives.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed and dated, written informed consent prior to any study specific procedures
•Healthy male volunteer aged 18 to 50 years
•Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive

Exclusion Criteria

•History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
•History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
•Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP
•Any clinically important abnormalities in clinical chemistry, endocrine hormones, hematology, or urinalysis results as judged by the Investigator

Arms & Interventions

AZD1979

Single ascending doses of oral solution AZD1979

Intervention: AZD1979

Placebo

Placebo to match single ascending doses of oral solution AZD1979

Intervention: Placebo to match

Outcomes

Primary Outcomes

Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood

Time Frame: Up to 62 days