Overview
The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001.
The main questions it aims to answer are:
Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain?
Participants will:
Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.
Eligibility
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.