AZD0914 Phase 1 ADME Study in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.

Key facts

Study ID

NCT02298920

Run by

Entasis Therapeutics

People needed

6

Starts

2015-01-01

Expected to finish

2015-02-01

Last updated by the study team

2015-06-03

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States
• Research Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.