Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT01311635
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
* Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
* Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.
Exclusion Criteria:
* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
* Prolonged QTcF \>450 ms or shortened QTcF\<340 ms at Visit 1 or family history of long QT syndrome
* History of, or current alcohol or drug abuse
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01311635
Study Brief:
Protocol Section:
NCT01311635