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

Detailed criteria

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

Drug
LY4515100
Administered Orally
Drug
Placebo
Administered Orally

Location

JBR Clinical Research
Salt Lake City, Utah

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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