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 |
|
|
Placebo Comparator Placebo |
Administered Orally |
|
Recruiting Locations
JBR Clinical Research
Salt Lake City, Utah 84107
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) or1-317-615-4559
LillyTrials@Lilly.com