A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Oral Dose of LY4515100, in Participants Experiencing Moderate-to-Severe Acute Pain Following Surgical Removal of Impacted Third Molars
Eli Lilly and Company
Summary
The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical pain after removing impacted third molars. For each participant, the study may last approximately 6 weeks and will include a stay in a Clinical Research Unit (CRU) after third molar removal.
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²) inclusive. * Participant requires extraction of 2 or more third molars, including 2 mandibular molars with partial or full bony impaction, confirmed by panoramic X-ray. Exclusion Criteria: * Prior dental surgery within 60 days before screening or history of other surgical procedures that could confound surgery or postoperative procedures. * Diagnosis of chronic pain conditions that could confound postsurgical pain reporting in the opinion of the investigator. * Positive ur…
Interventions
- DrugLY4515100
Administered Orally
- DrugPlacebo
Administered Orally
Location
- JBR Clinical ResearchSalt Lake City, Utah