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

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AstraZeneca

Status and phase

Terminated
Phase 1

Conditions

Healthy Subjects

Treatments

Drug: AZD1979
Drug: Placebo to match

Study type

Interventional

Funder types

Industry

Identifiers

NCT02072993
D3930C00001

Details and patient eligibility

About

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.

Enrollment

116 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

116 participants in 2 patient groups, including a placebo group

AZD1979
Experimental group
Description:
Single ascending doses of oral solution AZD1979
Treatment:
Drug: AZD1979
Placebo
Placebo Comparator group
Description:
Placebo to match single ascending doses of oral solution AZD1979
Treatment:
Drug: Placebo to match

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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