An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty

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.

Inclusion Criteria:

• Subject is male or female aged 18 to 65 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.