A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy Males

Phase 1

Terminated

• Conditions: Healthy Subjects
• Interventions: Drug: Placebo to match; Drug: AZD1979

• Registration Number: NCT02072993
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Study Start: 2014-03
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to match	Placebo to match single ascending doses of oral solution AZD1979
AZD1979	AZD1979	Single ascending doses of oral solution AZD1979

Primary Outcome Measures

Name	Time	Method
Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood	Up to 62 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of AZD1979 assessed by means of plasma concentration analyses	up to 48 hours post dose

Trial Locations

Locations (1)

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