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 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT01511159
Eligibility Criteria:
Inclusion Criteria:
* No clinically important abnormal physical findings
* No clinically relevant abnormalities in the results of laboratory screening evaluation
* Normal (or abnormal but not clinically significant) ECG (electrocardiogram)
* Normal (or abnormal but not clinically significant) blood pressure and heart rate
* Body Mass Index (BMI) between 20-30 kg/m\^2 or outwith range but not clinically significant
* Non-smoker
* Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height
* FVC ratio at least 75% of predicted normal for age, gender and height
Exclusion Criteria:
* A clinically significant illness or infection requiring treatment within the last two months
* Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis
* Subjects with first and/or second degree relative(s) with diabetes mellitus
* Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry
* Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port
* Current addiction to alcohol or substances of abuse
* Females
* Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01511159
Study Brief:
Protocol Section:
NCT01511159