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:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01531920
Eligibility Criteria:
Inclusion:
* Healthy male and female subjects
* Females agreed to use two medically acceptable methods of contraception, unless they were surgically sterile
* Aged 18-55 yrs, inclusive
* Achieved a Continuous Tracking Test (CTT )score increase of \>1.5 pixels from pre-alcohol when dosed with alcohol during the Screening Period (Day minus 8 plus/minus 2 days)
* Had a current driving license and drove regularly (e.g., more than 1000 miles a year (Part B only)
Exclusion:
* Any history of significant alcohol abuse or psychiatric disease, requiring inpatient admission or prolonged treatment with psychotropic medication
* Unable to follow the instructions for the psychometric testing
* Intolerant to the driving simulator (Part B only)
* Unable to adhere to long periods of confinement (subjects who could not follow the instructions of the protocol, including the meals)
* Use of prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to Screening (unless drug had a long half life \[i.e., 5 x t 1/2\>2 weeks\]) with the exception of paracetamol (up to 4 g/day), which was allowed up to 12 hours prior to dosing
* Had taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, or Seville orange products)
* Had taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01531920
Study Brief:
Protocol Section:
NCT01531920