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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT02418650
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy males
* Aged 50 to 65 years (inclusive)
* Normal weight defined as a body mass index (BMI) of \>18.5 and \<32.0 kg/m2
* Weight 55 to 100 kg (inclusive)
* Adequate method of contraception during the study and for a period of 6 months after study drug administration
Key exclusion Criteria:
* Evidence of clinically significant disease
* Intake of any medication that could affect the outcome of the study
* Known hypersensitivity to the active substances or the excipients of the drug or any serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* History of anaphylactic/anaphylactoid reactions
* Clinically significant abnormal biochemistry, haematology or urinalysis
* Current or history of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current use or use within the last 12 months of nicotine products
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
* Presence or history of clinically significant allergy requiring treatment
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT02418650
Study Brief:
Protocol Section:
NCT02418650