Status:
COMPLETED
AZD0914 Phase 1 ADME Study in Healthy Volunteers
Lead Sponsor:
Entasis Therapeutics
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.
Detailed Description
This is an open-label, single dose study in 6 healthy male subjects aged 18 to 55 years. Each subject will be admitted to the clinical pharmacology unit on the day prior to dosing Check in (Day -1) an...
Eligibility Criteria
Inclusion
- Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture;
- Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements;
- Within body mass index (BMI) range 19 to 30 kg/m2, inclusive, at screening;
- Non-smokers in past 6 months;
- In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs as judged by the Investigator;
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, interfere with absorption, distribution, metabolism or excretion of drugs, or influence the results or the subject's ability to participate in the study;
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QT interval corrected for heart rate (QTc) changes;
- Any clinically significant abnormalities in clinical chemistry, hematology, or UA results as judged by the Investigator;
- Abnormal vital signs, after 10 minutes supine rest, confirmed by repeat, defined as any of the following: systolic blood pressure \<90 mmHg or \>140 mmHg; diastolic blood pressure \<50 mmHg or \>90 mmHg; or heart rate \<40 or \>100 beats per minute;
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP;
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02298920
Start Date
January 1 2015
End Date
February 1 2015
Last Update
June 3 2015
Active Locations (2)
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1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
2
Research Site
Madison, Wisconsin, United States