Acute Postoperative PainPhase 1/2NCT07905105
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
A Phase 1/2 study testing CYT-1010 in people with Acute Postoperative Pain and Dental Pain, run by Cytogel Pharma, LLC at 1 site in United States.
Trial summary
The primary objective of this trial is to assess the safety and tolerability of single, ascending doses of CYT-1010 in healthy male and female volunteers and in the treatment of acute postoperative pain after third molar extraction. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Postoperative Pain, Dental Pain
- What is being tested?
- CYT-1010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a male or female, 18-45 years of age, able and willing to provide written informed consent to participate in the trial.
- Be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG).
- Have body mass index (BMI) of 19-35 kg/m^2.
- (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.
- (Dental Pain participants only): Planned extraction of three (3) third molars with at least two of which are ≥50% impacted mandibular molars.
- 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.
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- Have normal O2 saturation levels (95% to 100%).
- Have normal laboratory parameters values within the normal range or considered non-clinically significant by the Investigator.
- 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.
- Have a negative urine drug test (UDT) at screening.
- Non-smoker.
- Be able to read and communicate meaningfully in English and comply with all trial procedures.
- Be willing to voluntarily sign an informed consent form (ICF), prior to the conduct of any trial-specific procedures.
- 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).
- 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.
Who cannot join
- 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).
- 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.
- 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).
- Have a history of drug abuse or any positive findings in UDT.
- Have a history of an upper gastrointestinal (GI) disorder within 6 months of screening.
- Have contraindications to trial medication (opioids, nonsteroidal anti-inflammatory drug [NSAIDs]).
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- Bleeding disorder, dysphagia, serious complications after molar extraction, or chronic hepatic, renal, or GI disease.
- Have been administered a systemic corticosteroid within 1 month prior to surgery (inhaled or topical steroids are allowed).
- Have a history of congestive heart failure.
- Have a family history of significant cardiac disease (i.e. sudden death in first degree relative; myocardial infarction prior to 50 years old).
- Have a history of seizures or any type of seizure disorder.
- Have a history of cognitive or psychiatric disorders or any other condition that could interfere with compliance with trial procedures.
- Have a history of drug or alcohol abuse within one year prior to screening.
- Use of any other investigational drug within 1 month prior to enrollment.
- Donation and/or receipt of any blood or blood product within 1 month prior to enrollment.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CenExel SLC
Salt Lake City, Utah, 84107
Todd Bertoch
About this study
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
The primary objective of this trial is to assess the safety and tolerability of single, ascending doses of CYT-1010 in healthy male and female volunteers and in the treatment of acute postoperative pain after third molar extraction.
- Conditions
- Acute Postoperative Pain, Dental Pain
- Being tested
- CYT-1010, Placebo
- Keywords
- CYT-1010, Third molar extraction, Dental surgery, Opioid analgesic
- Medical subject headings
- Pain, Postoperative, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT-1010Drug
Single intravenous (IV) dose of 5 mg or 10 mg CYT-1010.
PlaceboDrug
20% hydroxypropyl-β-cyclodextrin, approximately 0.01 N HCl, IV sterile injection delivered as a single IV dose.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers: CYT-1010 5 mg | Experimental | Participants in Cohort 1a will receive a single 5 mg intravenous dose of CYT-1010. Receives: Drug: CYT-1010 |
| Healthy Volunteers: CYT-1010 10 mg | Experimental | Participants in Cohort 2a will receive a single 10 mg intravenous dose of CYT-1010. Receives: Drug: CYT-1010 |
| Healthy Volunteers: Placebo | Placebo comparator | Participants in Cohorts 1a and 2a will receive a single intravenous dose of matching placebo. Receives: Drug: Placebo |
| Dental Pain: CYT-1010 5 mg | Experimental | Participants in Cohort 1b will receive a single 5 mg intravenous dose of CYT-1010. Receives: Drug: CYT-1010 |
| Dental Pain: CYT-1010 10 mg | Experimental | Participants in Cohort 2b will receive a single 10 mg intravenous dose of CYT-1010. Receives: Drug: CYT-1010 |
| Dental Pain: Placebo | Placebo comparator | Participants in Cohorts 1b and 2b will receive a single intravenous dose of matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
Measured: From trial drug administration through Day 7
Sum of Pain Intensity Differences (SPID) Over 2 Hours (SPID2) in Dental Pain Participants
SPID2 is the time-weighted SPID over 0-2 hours after receiving medication, derived from postoperative dental pain assessed on a 0-10 numerical rating scale (NRS). NRS is a categorical 0-10 pain rating scale wherein 0 is defined as "no pain" and 10 is the "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity.
Measured: From pre-dose to 2 hours post-dose
Secondary outcomes (19)
Maximum Observed Plasma Concentration (Cmax) of CYT-1010
Measured: Pre-dose through 8 hours post-dose
Time to Cmax (Tmax) of CYT-1010
Measured: Pre-dose through 8 hours post-dose
Area Under the Concentration-time Curve (AUC) From 0 to Last Measurable Concentration (AUC0-t) of CYT-1010
Measured: Pre-dose through 8 hours post-dose
AUC From 0 to Infinity (AUC0-inf) of CYT-1010
Measured: Pre-dose through 8 hours post-dose
Elimination Rate Constant (Kel) of CYT-1010
Measured: Pre-dose through 8 hours post-dose
Apparent total body clearance (CL) of CYT-1010
Measured: Pre-dose through 8 hours post-dose
Total Volume of Distribution (Vss) of CYT-1010
Measured: Pre-dose through 8 hours post-dose
Elimination Half-life (T1/2) of CYT-1010 of CYT-1010
Measured: Pre-dose through 8 hours post-dose
Oxygen (O2) Saturation AUC
Measured: Pre-dose through 8 hours post-dose
Transcutaneous Partial Pressure of Carbon Dioxide (pCO2) AUC
Measured: Pre-dose through 8 hours post-dose
Respiratory rate AUC
Measured: Pre-dose through 8 hours post-dose
SPID
SPID at other times is the time-weighted Summed Pain Intensity Difference over specified time intervals after receiving medication, derived from postoperative dental pain assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity.
Measured: Pre-dose through Day 7 post-dose
NRS Pain Intensity Scores
NRS is a categorical 0-10 pain rating scale wherein 0 is defined as "no pain" and 10 is the "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity.
Measured: Pre-dose through Day 7 post-dose
Median Time to Confirmed Perceptible Pain Relief
Time to confirmed perceptible and meaningful pain relief is measured with the two stopwatch method, with one stopwatch to note first perceptible pain relief and the other stopwatch to note first time to meaningful pain relief.
Measured: From trial drug administration through 8 hours post-dose
Time to First Use of Rescue Medication
The duration of analgesia generally is defined by the median time to a request for rescue medication. The median time to the first use of rescue medication will be captured from administration of trial medication to first administration of rescue medication.
Measured: From trial drug administration through 8 hours post-dose
Total Dose of Rescue Medication Consumed
Measured: From trial drug administration through 8 hours post-dose
Participant Global Assessment at 3, 8 and 24 hours Post-dose
The participant will assess his/her global status of pain relief at designated time periods according to a 5-point categorical scale. The assessment should be based on the following question: "How would you rate the trial drug you were administered for pain relief?" with available Likert (word) scores translated to numerical scores as follows: Poor = 0, Fair = 1, Good = 2, Very Good = 3, or Excellent = 4. Higher scores indicate a greater level of pain relief.
Measured: At 3, 8, and 24 hours post-dose
Nurse-observer's Assessment of Sedation Score
Nurse-observer's sedation score will be assessed using the Ramsay Sedation Scale (RSS), ranging from 1 to 6, where 1: indicates the participant is anxious, agitated, or restless; 2: indicates the participant is cooperative, oriented, and tranquil; 3: indicates the participant responds to commands only; 4: indicates a brisk response to a light glabellar tap or loud auditory stimulus; 5: indicates a sluggish response to a light glabellar tap or loud auditory stimulus; and 6: indicates no response to these stimuli. Higher scores indicate a greater level of sedation.
Measured: Pre-dose through 24 hours post-dose
Number of Participants Using Antiemetics During the 8-hour Post-dose Period
Measured: From trial drug administration through 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start25 Sep 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytogel Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Bertoch, Study director, Cenexel JBR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905105
- Sponsor's protocol ID
- CYT-1010-1-02
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07905105
- Acronym / sponsor ID
- CYT-1010-1-02
- Conditions
- Acute Postoperative Pain, Dental Pain
- Keywords
- CYT-1010, Third molar extraction, Dental surgery, Opioid analgesic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cytogel Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to assess the safety and tolerability of single, ascending doses of CYT-1010 in healthy male and female volunteers and in the treatment of acute postoperative pain after third molar extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers: CYT-1010 5 mg | Experimental | Drug: CYT-1010Participants in Cohort 1a will receive a single 5 mg intravenous dose of CYT-1010. |
| Healthy Volunteers: CYT-1010 10 mg | Experimental | Drug: CYT-1010Participants in Cohort 2a will receive a single 10 mg intravenous dose of CYT-1010. |
| Healthy Volunteers: Placebo | Placebo comparator | Drug: PlaceboParticipants in Cohorts 1a and 2a will receive a single intravenous dose of matching placebo. |
| Dental Pain: CYT-1010 5 mg | Experimental | Drug: CYT-1010Participants in Cohort 1b will receive a single 5 mg intravenous dose of CYT-1010. |
| Dental Pain: CYT-1010 10 mg | Experimental | Drug: CYT-1010Participants in Cohort 2b will receive a single 10 mg intravenous dose of CYT-1010. |
| Dental Pain: Placebo | Placebo comparator | Drug: PlaceboParticipants in Cohorts 1b and 2b will receive a single intravenous dose of matching placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Be a male or female, 18-45 years of age, able and willing to provide written informed consent to participate in the trial.
- Be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG).
- Have body mass index (BMI) of 19-35 kg/m^2.
- (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.
- (Dental Pain participants only): Planned extraction of three (3) third molars with at least two of which are ≥50% impacted mandibular molars.
Key exclusion criteria (16 listed)
- 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).
- 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.
- 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).
- Have a history of drug abuse or any positive findings in UDT.
- Have a history of an upper gastrointestinal (GI) disorder within 6 months of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT-1010Single intravenous (IV) dose of 5 mg or 10 mg CYT-1010. | Drug | Dental Pain: CYT-1010 10 mg, Dental Pain: CYT-1010 5 mg, Healthy Volunteers: CYT-1010 10 mg, Healthy Volunteers: CYT-1010 5 mg |
| Placebo20% hydroxypropyl-β-cyclodextrin, approximately 0.01 N HCl, IV sterile injection delivered as a single IV dose. | Drug | Dental Pain: Placebo, Healthy Volunteers: Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From trial drug administration through Day 7
Sum of Pain Intensity Differences (SPID) Over 2 Hours (SPID2) in Dental Pain Participants
Time frame: From pre-dose to 2 hours post-dose
SPID2 is the time-weighted SPID over 0-2 hours after receiving medication, derived from postoperative dental pain assessed on a 0-10 numerical rating scale (NRS). NRS is a categorical 0-10 pain rating scale wherein 0 is defined as "no pain" and 10 is the "pain as bad as you can imagine". Higher scores indicate a greater level of pain intensity.
19 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Time to Cmax (Tmax) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Area Under the Concentration-time Curve (AUC) From 0 to Last Measurable Concentration (AUC0-t) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
AUC From 0 to Infinity (AUC0-inf) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Elimination Rate Constant (Kel) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Apparent total body clearance (CL) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Total Volume of Distribution (Vss) of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Elimination Half-life (T1/2) of CYT-1010 of CYT-1010
Time frame: Pre-dose through 8 hours post-dose
Oxygen (O2) Saturation AUC
Time frame: Pre-dose through 8 hours post-dose
Transcutaneous Partial Pressure of Carbon Dioxide (pCO2) AUC
Time frame: Pre-dose through 8 hours post-dose
Respiratory rate AUC
Time frame: Pre-dose through 8 hours post-dose
SPID
Time frame: Pre-dose through Day 7 post-dose
NRS Pain Intensity Scores
Time frame: Pre-dose through Day 7 post-dose
Median Time to Confirmed Perceptible Pain Relief
Time frame: From trial drug administration through 8 hours post-dose
Time to First Use of Rescue Medication
Time frame: From trial drug administration through 8 hours post-dose
Total Dose of Rescue Medication Consumed
Time frame: From trial drug administration through 8 hours post-dose
Participant Global Assessment at 3, 8 and 24 hours Post-dose
Time frame: At 3, 8, and 24 hours post-dose
Nurse-observer's Assessment of Sedation Score
Time frame: Pre-dose through 24 hours post-dose
Number of Participants Using Antiemetics During the 8-hour Post-dose Period
Time frame: From trial drug administration through 8 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Todd Bertoch study director
Cenexel JBR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYT-1010 in people with Acute Postoperative Pain and Dental Pain, run by Cytogel Pharma, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Hunt (801-261-2000, j.hunt@cenexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: From trial drug administration through Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.