Overview
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914
Status:
Completed
Completed
Trial end date:
2014-03-01
2014-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
AstraZeneca
Criteria
Inclusion Criteria:- Healthy male and female (of non-childbearing potential)subjects aged 18 to55 years
(inclusive).
- Have a body mass index (BMI) between 18.00 and 30.50 kg/m2 and weigh at least 50 kg
and no more than 100 kg
- Male subjects should be willing to use barrier contraception, ie, condoms, from the
day of dose administration until at least 3 months after dose administration of the IP
Exclusion Criteria:
- History of any important clinically significant disease or disorder which, in the
opinion of the PI, may either put the subject at risk because of participation in the
study, or influence the results or the subject'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
from the first administration of IP as judged by the PI
- History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion
symptoms >3 times a week, or blood in stool in previous 6 months not related to anal
trauma