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

NCT02072993 | Terminated Phase 1

• 1 other identifier: D3930C00001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Phase I, healthy, pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacokinetics of AZD1979 assessed by means of plasma concentration analyses

  up to 48 hours post dose

Study Arms (2)

AZD1979

EXPERIMENTAL

Single ascending doses of oral solution AZD1979

Drug: AZD1979

Placebo

PLACEBO COMPARATOR

Placebo to match single ascending doses of oral solution AZD1979

Drug: Placebo to match

Interventions

AZD1979 DRUG

Single dose, oral solution administration

AZD1979

Placebo to match DRUG

Single dose, oral solution administration

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

AZD1979

Study Officials

• Eleanor Lisbon, MD

  Quintiles 6700 W 115th Street, Overland Park, KS USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

US (1)