Acute Pain, Molar, Molar, Third, Surgery, Oral
Conditions
Brief 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.
Interventions
DRUGLY4515100
Administered Orally
DRUGPlacebo
Administered Orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Self-Reported Pain Intensity | Baseline, Up to Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale | Baseline, Up to Day 1 |
| Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale | Baseline, Up to Day 1 |
| Time to Rescue Medications | Baseline, Up to Day 1 |
| Participants Overall Impression of Pain Relief on a Five-Point Scale | Baseline, Up to Day 1 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4515100 | Baseline, Up to Day 1 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed