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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01048203
Eligibility Criteria:
Inclusion Criteria:
1. 40-65 year old male and female subjects.
2. Healthy according to medical history, physical examination and clinical chemistry, urine and hematological laboratory tests.
3. Body Mass Index (BMI) of 18-30.
4. Negative screen for Hepatitis B / C and HIV-infection.
5. Be willing and able to comply with the protocol for the duration of the study.
6. Women of childbearing potential must be neither pregnant nor breast-feeding. Confirmation that the subject is not pregnant must be established by a pregnancy test before the single dose and at study end. Fertile women must be willing to practice reliable methods of contraception. Medically accepted safe methods of contraception for the purpose of this study will include surgical sterilisation, intra-uterine device, diaphragm with spermicide, or condom with spermicide. As interaction studies between ABR-215050 and hormonal (oral or depot) contraceptives have not yet been performed, women using such devices must also use a complementary contraceptive device.
7. Have given written signed informed consent, prior to start of any study-related activities.
Exclusion Criteria:
1. Gastrointestinal disorders that may affect drug absorption.
2. Any vaccination within 30 days before start of this study and throughout the study.
3. Blood donation within 90 days before start of this study and for 90 days after the study.
4. Participation in other clinical studies or who have received other investigational drugs within 90 days prior to enrolment. Additionally, subjects previously included into this study and then are withdrawn from the study is not to be re-entered into the study.
5. Perform any planned surgery
6. Any use of nicotine within three (3) months before start of this study and throughout the study.
7. Known or suspected history of alcoholism or drug abuse.
8. Intake of alcoholic beverages for 24 hours prior to the administration of investigational product and for 24 hours after the dose.
9. Intake of caffeine containing beverages 10 hours prior to the administration of investigational product and for 6 hours after the dose.
10. Medication including herbal remedies (vitamins and paracetamol excluded) within 14 days before and throughout the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01048203
Study Brief:
Protocol Section:
NCT01048203