Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction

Halia Therapeutics

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: HT-6184; Drug: HT-6184 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06241742

HT-6184-PIR-001

Details and patient eligibility

About

The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.

The main question it aims to answer are:

• Does HT-6184 decrease inflammation in patients after third molar removal?
• Does HT-6184 decrease pain in patients after third molar removal?

Participants will be asked to do the following during the clinical trial:

• Take a single oral dose of HT-6184 or placebo
• Allow a oral surgeon remove their third molar teeth
• Blood draws on 5 occurrences
• Rate their pain intensity
• Attend two follow-up appointments on day 1 and day 2 after third molar removal
• Participate in one follow-up phone call 5-7 days after third molar removal

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The candidate is 18 years of age or older, capable of understanding and providing written informed consent to participate and willing to comply with study procedures including providing a blood sample to be saved for potential pharmacokinetic and/or genetic analysis.
• The candidate, for any reason, requires surgical extraction of two or more third molars of which at least one is partially or fully impacted in mandibular bone.
• The candidate is postmenopausal, surgically sterile or agrees to use an effective and medically acceptable method of contraception for 1 week after his or her last dose of study drug.
• If female with child-bearing potential, the candidate must have a negative pregnancy test at screening and pre-surgery on the day of surgery.

Exclusion criteria

• The candidate typically or on average consumes more than one alcoholic beverage per day.
• The candidate is pregnant or nursing.
• The candidate has received an investigational drug or used an experimental medical device within 30 days prior to screening.
• The candidate has donated 1 or more pints of blood within 8 weeks prior to screening.
• The candidate has any hypersensitivity to components of the HT-6184/placebo formulations or the protocol-specified analgesic rescue medication, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
• The candidate has any contraindication to oral surgery or any serious or major medical problems that, in the investigator's opinion, may compromise the safety or the candidate or interfere with the interpretation of study results
• The candidate has taken acetaminophen, NSAIDs (including aspirin) or other medications for pain within 72 hours of the surgical procedure.
• The candidate has any abnormal laboratory value or physical finding that, in the opinion of the investigator, may compromise the individual's safety, interfere with interpretation of the study results, or be indicative of an underlying disease state.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

HT-6184 Treatment Arm

Active Comparator group

Treatment:

Drug: HT-6184

HT-6184 Placebo

Placebo Comparator group

Treatment:

Drug: HT-6184 Placebo