This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars

Latigo Biotherapeutics

Status and phase: Enrolling; Phase 2

Conditions: Acute Pain, Postoperative

Treatments: Drug: Suzetrigine; Drug: LTG-001 Mid Dose; Drug: LTG-001 High Dose; Drug: LTG-001 Low Dose; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06774625

LTG-001-003

Details and patient eligibility

About

The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are:

Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours?

Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain.

Participants will:

Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up.

Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is male or female aged 18 to 50 years, inclusive, at the time of signing the informed consent
• Has a body weight ≥ 45 kg and a BMI ≤ 35 kg/m2.
• Subject requires extraction of 2 or more third molars, two of which must be mandibular molars that must be fully or partially bony, or combination of one fully and one partially bony impaction.
• Subject must agree to study required use of birth control.
• Post-surgical pain must meet protocol requirements.

Exclusion criteria

• Inability to take oral medications
• Prior dental surgery within 60 days or other surgical history that could confound surgery or post-operative procedures.
• 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.
• Participant is under legal custodianship.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 5 patient groups, including a placebo group

LTG-001 High Dose

Experimental group

Treatment:

Drug: LTG-001 High Dose

LTG-001 Mid Dose

Experimental group

Treatment:

Drug: LTG-001 Mid Dose

LTG-001 Low Dose

Experimental group

Treatment:

Drug: LTG-001 Low Dose

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Suzetrigine

Active Comparator group

Treatment:

Drug: Suzetrigine