Phase
Condition
Inflammation
Pain
Treatment
HT-6184
HT-6184 Placebo
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The candidate is 18 years of age or older, capable of understanding and providingwritten informed consent to participate and willing to comply with study proceduresincluding providing a blood sample to be saved for potential pharmacokinetic and/orgenetic analysis.
The candidate, for any reason, requires surgical extraction of two or more thirdmolars of which at least one is partially or fully impacted in mandibular bone.
The candidate is postmenopausal, surgically sterile or agrees to use an effectiveand medically acceptable method of contraception for 1 week after his or her lastdose of study drug.
If female with child-bearing potential, the candidate must have a negative pregnancytest at screening and pre-surgery on the day of surgery.
Exclusion
Exclusion Criteria:
The candidate typically or on average consumes more than one alcoholic beverage perday.
The candidate is pregnant or nursing.
The candidate has received an investigational drug or used an experimental medicaldevice within 30 days prior to screening.
The candidate has donated 1 or more pints of blood within 8 weeks prior toscreening.
The candidate has any hypersensitivity to components of the HT-6184/placeboformulations or the protocol-specified analgesic rescue medication, aspirin ornonsteroidal anti-inflammatory drugs (NSAIDs).
The candidate has any contraindication to oral surgery or any serious or majormedical problems that, in the investigator's opinion, may compromise the safety orthe candidate or interfere with the interpretation of study results
The candidate has taken acetaminophen, NSAIDs (including aspirin) or othermedications for pain within 72 hours of the surgical procedure.
The candidate has any abnormal laboratory value or physical finding that, in theopinion of the investigator, may compromise the individual's safety, interfere withinterpretation of the study results, or be indicative of an underlying diseasestate.
Study Design
Connect with a study center
CenExel JBR
Murray, Utah 84107
United StatesSite Not Available
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