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

Pain Clinical Trial

Official title:

A Phase-2 Study to Evaluate the Ability of HT-6184 to Attenuate Diagnostic Biomarkers of Post-procedure Acute Inflammation and Manage Pain Following Third Molar Extraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241742
• Other study ID #: HT-6184-PIR-001
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2024
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Halia Therapeutics, Inc.
• Contact: Halia Medical Monitor
• Phone: 385-355-4315
• Email: PIR001monitor[@]haliatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Pain

Intervention

Drug:
• HT-6184
Single, oral dose of HT-6184
• HT-6184 Placebo
Single, oral dose of placebo

Locations

Country	Name	City	State
United States	CenExel JBR	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Halia Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum C-reactive protein levels from pre-dose		Up to 54 hours post surgery
Primary	Incidence of adverse events	Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Up to 7 days post surgery
Primary	Incidence of serious adverse events	Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Up to 7 days post surgery
Secondary	Area under the categorical pain intensity-by-time curve (AUCs)		Up to 8 hours after surgery