Trials Today

A Study of LY4515100 in Participants With Pain Following Third Molar Removal

Purpose

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.

Conditions

Acute Pain
Molar
Molar, Third
Surgery, Oral

Eligibility

Eligible Ages: Between 18 Years and 40 Years
Eligible Sex: All
Accepts 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 urine drug screen or alcohol test during screening or on the day of surgery. - Evidence or history of any other clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases, in the opinion of the investigator, within the last 5 years. - History of malignancy of any organ system treated or untreated, within 5 years prior to consent. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell carcinoma of the skin, or localized squamous carcinoma of the skin if the participant has been treated and is considered cured.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental LY4515100	Administered Orally	Drug: LY4515100 Administered Orally
Placebo Comparator Placebo	Administered Orally	Drug: Placebo Administered Orally

Recruiting Locations

JBR Clinical Research
Salt Lake City, Utah 84107

More Details

NCT ID: NCT07511816
Status: Recruiting
Sponsor: Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.