CYT-1010 in healthy volunteers and after third molar extraction
Official title: A Randomized, Double-blind, Single-dose, Placebo-controlled Pharmacokinetic and Proof-of-concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and in Subjects With Moderate to Severe Pain After Third Molar Extraction
Run by Cytogel Pharma, LLC · NCT07905105 · Data updated 2026-11-12
This trial tests CYT-1010, at single rising doses, for safety and tolerability in healthy adults and in people experiencing pain after removing wisdom teeth.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Cytogel Pharma, LLC Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | September 25, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07905105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults or adults aged 18-45 with planned three-tooth wisdom extraction and generally good health, suitable for confinement and safety monitoring.
✕Probably not a fit
Patients with medical conditions or demographics outside the inclusion criteria or with contraindications to the study drug may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study combines Phase 1 and Phase 2 to evaluate CYT-1010, a novel intervention, in two groups: healthy volunteers and patients with acute dental postoperative pain following third molar extraction. Participants receive CYT-1010 or placebo, with safety, tolerability, and basic pharmacodynamic measures monitored. The dental-pain cohort will help determine how the drug performs in an acute pain setting after dental surgery. Healthy volunteers will undergo short confinement for safety assessments and serial labs, while the dental group will have standard postoperative follow-up. Overall, the trial aims to establish initial safety and potential signal of analgesic effect in a controlled environment.
Why it matters
Potential benefit: If successful, CYT-1010 could offer a new analgesic option for acute dental pain and inform dosing for further development.
How similar studies have gone: Previous early-phase studies with CYT-1010 or similar compounds have shown safety signals in healthy volunteers and pain settings, but results are exploratory and require confirmation in larger trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be a male or female, 18-45 years of age, able and willing to provide written informed consent to participate in the trial. 2. Be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG). 3. Have body mass index (BMI) of 19-35 kg/m\^2. 4. (Healthy Volunteer participants only): Willing to remain in confinement at the clinical trial unit for 1.5 consecutive days (one night) and to return to the unit at 7±2 days for a final AE assessment and additional blood tests and safety evaluations. 5. (Dental Pain participants only): Planned extraction of three (3) third molars with at least two of which are ≥50% impacted mandibular molars. 6. Have normal blood pressure (BP) \[systolic BP = 90-140 mmHg, diastolic BP = 45-90 mmHg\] and heart rate (HR) \[resting HR = 45-100 beats per minute (bpm) without medication. 7. Have normal O2 saturation levels (95% to 100%). 8. Have normal laboratory parameters values within the normal range or considered non-clinically significant by the Investigator. 9. All women need to have a negative urine pregnancy test at screening. On the morning of dosing or surgery, women of childbearing potential must have a negative pregnancy test. 10. Have a negative urine drug test (UDT) at screening. 11. Non-smoker. 12. Be able to read and communicate meaningfully in English and comply with all trial procedures. 13. Be willing to voluntarily sign an informed consent form (ICF), prior to the conduct of any trial-specific procedures. 14. Male participants and their female sexual partners must agree to use double barrier contraception during the trial period and for 2 months afterward, or provide proof of surgical sterility, or abstain from heterosexual coital sexual activity (heterosexual abstinence is considered to be a highly effective method only if the participant agrees to refrain from heterosexual intercourse during the entire period from 30 days prior to screening to 90 days after the last trial drug administration). 15. Female participant will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year or surgically sterile for at least 3 months, or will agree to use double-barrier contraception for 28 days and/or from their last confirmed menstrual period prior to trial enrollment (whichever is longer) until 2 months after Clinic Discharge. Exclusion Criteria: 1. Participants taking any type of medication on a regular basis will be excluded from participation in the trial (females will be allowed to continue using oral contraceptives). 2. Using any pain medication on a regular schedule; participants taking pain medication occasionally as needed will be allowed in the trial as long as they agree to discontinue all pain medication for at least 24 hours (or 5 half-lives, whichever is longer) before surgery and during the trial. 3. Using centrally acting substances during or for up to 14 days prior to entering the trial (i.e., hypnotics, sedatives, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, first generation antihistamines and sympathomimetic amines). 4. Have a history of drug abuse or any positive findings in UDT. 5. Have a history of an upper gastrointestinal (GI) disorder within 6 months of screening. 6. Have contraindications to trial medication (opioids, nonsteroidal anti-inflammatory drug \[NSAIDs\]). 7. Bleeding disorder, dysphagia, serious complications after molar extraction, or chronic hepatic, renal, or GI disease. 8. Have been administered a systemic corticosteroid within 1 month prior to surgery (inhaled or topical steroids are allowed). 9. Have a history of congestive heart failure. 10. Have a family history of significant cardiac disease (i.e. sudden death in first degree relative; myocardial infarction prior to 50 years old). 11. Have a history of seizures or any type of seizure disorder. 12. Have a history of cognitive or psychiatric disorders or any other condition that could interfere with compliance with trial procedures. 13. Have a history of drug or alcohol abuse within one year prior to screening. 14. Use of any other investigational drug within 1 month prior to enrollment. 15. Donation and/or receipt of any blood or blood product within 1 month prior to enrollment. 16. Have, in the judgment of the Investigator, a condition that would pose a risk to the participant, interfere with the participant's ability to complete the trial, or confound the trial results.
Where it's running
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CenExel SLC
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Jenny Hunt
- Email: j.hunt@cenexel.com
- Phone: 801-261-2000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.