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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT02821312
Eligibility Criteria:
Inclusion Criteria:
* BMI between 18.0 and 32.0 kg/m2
* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Exclusion Criteria:
* Subjects who do not agree to use a method of acceptable contraception
* Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control
* Consume more than 28 or 21 units of alcohol per week if male or female, respective
* Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration
* Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration
* Systolic blood pressure \< 90 mmHg or \> 140 mmHg
* Diastolic blood pressure \< 50 mmHg or \> 90 mmHg
* Pulse rate \< 45 bpm or \> 100 bpm
* Positive urine drugs of abuse screen at screening or first admission
* Positive alcohol breath test at screening or first admission
* Positive cotinine test at screening or first admission
* Abnormality in the 12-lead ECG at screening, admission or predose on Day 1
* Subjects who are pregnant, breastfeeding, or lactating
* Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration
* Subjects who have a significant history of drug allergy, as determined by the Investigator
* Aspartate aminotransferase and/or Alanine aminotransferase ≥ 1.5 × upper limit of normal (ULN) or total bilirubin \> ULN at screening or admission
* Subjects who are carriers of HBsAg or hepatitis C antibody, have serum hepatitis or positive result for the test for HIV antibodies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02821312
Study Brief:
Protocol Section:
NCT02821312