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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT07102459
Eligibility Criteria:
Inclusion Criteria:
* Subject is male or female aged 18 to 50 years
* Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia
* Has a body BMI 18.0 to 35 kg/m2
* Has signed informed consent and will comply with the requirements and restrictions of the study
* Meet lifestyle, medication, or other study restrictions
* Subject must agree to study required use of birth control
* Post-surgical (abdominoplasty) pain must meet the study threshold
Exclusion Criteria:
* Inability to take oral medications
* Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications
* History of impaired hepatic function or heart disease.
* Abnormal liver laboratories or other lab abnormality indicative of serious medical condition
* Sensory abnormality that would confound post-surgery pain assessments
* Chronic use of NSAIDs, benzodiazepines, opioid use within the last year, use of medications that prolong QTc intervals, or other dietary and medication restrictions
* A subject with sleep apnea and/or on a home continuous positive airway pressure machine.
* Positive drug screen.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07102459
Study Brief:
Protocol Section:
NCT07102459