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TerminatedNCT02072993Updated Jul 29, 2014

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

A Phase 1 interventional study of AZD1979 and Placebo to match in Healthy Subjects, sponsored by AstraZeneca. Terminated at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-29.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Why this study was terminated
Study stopping criteria has been reached
Phase
Phase 1
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Phase I, healthy, pharmacokinetics
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    AZD1979

    Single ascending doses of oral solution AZD1979

    Drug: AZD1979

  • Placebo comparator
    Placebo

    Placebo to match single ascending doses of oral solution AZD1979

    Drug: Placebo to match

Interventions

  • DrugAZD1979

    Single dose, oral solution administration

  • DrugPlacebo to match

    Single dose, oral solution administration

06

What researchers measure

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

    Time frame: Up to 62 days

Secondary outcomes

  1. Pharmacokinetics of AZD1979 assessed by means of plasma concentration analyses

    Time frame: up to 48 hours post dose

07

Study locations

1 site
  • Research Site
    Overland Park, Kansas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02072993
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Feb 27, 2014
Start date
Mar 2014
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jul 29, 2014

Study contacts

Eleanor Lisbon, MD
principal investigator · Quintiles 6700 W 115th Street, Overland Park, KS USA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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