PainPhase 1NCT04683926
A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects
A Phase 1 study testing Desmetramadol in people with Pain, run by Syntrix Biosystems, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to investigate in healthy human subjects how much desmetramadol (Omnitram) gets in the blood after different oral doses are taken with or without food. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Desmetramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 18 Jan 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females with vital signs as follows at screening: systolic blood pressure > 90 mm Hg and < 140 mm Hg; diastolic blood pressure > 40 mm Hg and < 90 mm Hg; pulse 40 to 99 beats per minute; respiratory rate 12 to 24 breathes per minute.
- Age 19 to 55 years.
- Able and willing to give informed consent
- Able to comply with all study procedures.
- If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception from screening, throughout the study and for 30 days following study drug administration: hormonal (e.g., oral, transdermal, intravaginal, implant or injection for 3 months); double barrier (e.g., condom or diaphragm with spermicide); intrauterine device (IUD) or system (IUS) (for 3 months); vasectomized partner (6 months minimum); or abstinence.
- Screening laboratory results must be within normal range per clinical research unit: serum sodium, potassium, calcium, BUN, creatinine, ALT, AST, total bilirubin, alkaline phosphatase, glucose (random), albumin, total protein, WBC and differential, hemoglobin, and platelets. In addition PT and PTT must be < 1.2 ULN.
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- Electrocardiogram (ECG) without clinically significant abnormalities.
- Urinalysis demonstrating < +1 glucose, and +1 protein.
- If female, must have a negative pregnancy test at screening
- Negative urine test for substances of abuse, including opiates, per clinical pharmacology unit standards at screening and clinic check-in.
- Negative serology tests for HIV, hepatitis B surface antigen, and hepatitis C virus antibody.
- Weight > 50 Kg and a body mass index (BMI) of 18.0 to 32.0 kg/m (inclusive).
- Non-smoker of tobacco for a minimum of the past 3 months, and negative urine continine test.
Who cannot join
- Oral temperature > 38°C or current illness.
- History of seizures, epilepsy, or recognized increase risk of seizure (e.g., head trauma, metabolic disorders, alcohol or drug withdrawal).
- History of cirrhosis or laboratory evidence of liver disease.
- Having undergone gall bladder removal.
- Use of alcohol within 24 hours of day -1 until the end of the study; and grapefruit, grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), or grapefruit juice or grapefruit-related juices within 7 days of study drug administration and until the end of the study.
- History of previous anaphylaxis, severe allergic reaction to tramadol, codeine, or other opioid drugs.
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- Any other unstable acute or chronic disease that could interfere with the evaluation of the safety of the study drug as determined by the principal Investigator in dialogue with the Sponsor Medical Monitor.
- Females must not be currently pregnant or breast feeding.
- Unlikely to comply with the study protocol.
- Known or suspected alcohol or drug abuse within the past 6 months.
- Received another investigational agent within 4 weeks of Day -1, or within five half-lives of Day -1, whichever is longer; or receiving any other investigational agent during this study.
- Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol, or obscure interpretation of the trial data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized Single Oral Dose Cross-Over Study Investigating Desmetramadol Dose Proportionality And Food Effect In Normal Human Subjects
The purpose of the study is to investigate in healthy human subjects how much desmetramadol (Omnitram) gets in the blood after different oral doses are taken with or without food.
Read the detailed description
An open-label, randomized, balanced, single-dose, four-treatment, four-period, four-sequence (using a Williams' square design) cross-over study with each dose separated by >3 days. There are 4 sequences (Sequence 1, Sequence 2, Sequence 3, and Sequence 4), and 4 Periods (Period I, Period II, Period III, and Period IV). Sequence 1 order is 30 mg dose with food (Period I); 30 mg dose fasted (Period II), 10 mg dose fasted (Period III), and 20 mg dose fasted (Period IV). Sequence 2 order is 10 mg dose fasted (Period I); 30 mg dose with food (Period II), 20 mg dose fasted (Period III), and 30 mg dose fasted (Period IV). Sequence 3 order is 20 mg dose fasted (Period I); 10 mg dose fasted (Period II), 30 mg dose fasted (Period III), and 30 mg dose with food (Period IV). Sequence 4 order is 30 mg dose fasted (Period I); 20 mg dose fasted (Period II), 30 mg dose with food (Period III), and 10 mg dose fasted (Period IV).
To account for potential dropouts, up to 32 eligible subjects will be randomized to obtain a target sample of 24 subjects with PK responses at each of the four treatment periods (based on our completed phase 1 study in 43 subjects, dropouts are unlikely (~5%); see Section 1.2.2). Before each oral dose, subjects will be fasted overnight for at least 10 hours. Treatment sequences will include the following four unblinded single-dose oral treatments: 1) desmetramadol 1 x 10 mg tablet; 2) desmetramadol 2 x 10 mg tablets; 3) desmetramadol 3 x 10 mg tablets; and 4) desmetramadol 3 x 10 mg tablets following a high-fat, high-calorie breakfast served approximately 30 minutes before dosing and entirely consumed within 20 minutes. All subjects will fast for an additional four hours after desmetramadol administration. The fed treatment should be administered the desmetramadol dose approximately 30 minutes after the start of the meal. Desmetramadol will be administered with approximately 240 ml of water. No water is allowed one hour before and one hour after each desmetramadol administration.
This will be an inpatient study. Subjects will be admitted to the clinical pharmacology unit on Study Day -1, and administered a single oral dose treatment on Study Day 1, Study Day 4, Study Day 7 and Study Day 10. After completing study procedures on Day 11 the subject will be discharged from the facility.
Blood specimens for plasma preparation and PK analysis will be collected at the following times: pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, and 32 h.
- Conditions
- Pain
- Being tested
- Desmetramadol
- Keywords
- Pharmacokinetics, Food effect
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmetramadolDrug
Also called Omnitram
Analgesic
| Study group | Role | What they receive |
|---|---|---|
| Desmetramadol 10 mg, fasted | Experimental | While fasting a single oral dose of 10 mg desmetramadol under. Receives: Drug: Desmetramadol |
| Desmetramadol 20 mg, fasted | Experimental | While fasting a single oral dose of 20 mg desmetramadol. Receives: Drug: Desmetramadol |
| Desmetramadol 30 mg , fasted | Experimental | While fasting a single oral dose of 30 mg desmetramadol. Receives: Drug: Desmetramadol |
| Desmetramadol 30 mg , fed | Experimental | After feeding a single oral dose of 30 mg desmetramadol. Receives: Drug: Desmetramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
(-/+)-M1, AUC(0-32) and AUC(Inf)
The AUC(0-32) and AUC(inf) of (-/+)-M1 after each treatment (i.e., 10, 20 and 30 mg desmetramadol fasted, and 30 mg desmetramadol fed)
Measured: Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.
(-/+)-M1, Cmax
The Cmax of (-/+)-M1 after each treatment (i.e., 10, 20 and 30 mg desmetramadol fasted, and 30 mg desmetramadol fed)
Measured: Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.
Secondary outcomes (1)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Adverse events will include: 1) reports by participants; 2) observations by investigators; and 3) abnormal laboratory safety test results.
Measured: Participant report adverse events throughout study enrolment; investigators observe adverse events during all 11 days of inpatient treatment; laboratory safety labs are obtained on Day 11 (the final study day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start8 Jan 2021
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An open-label, randomized, balanced, single-dose, four-treatment, four-period, four-sequence (using a Williams' square design) cross-over study.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntrix Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Robert Schwab, MD, Principal investigator, CelerionStuart Kahn, MD, Study director, Syntrix Biosystems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683926
- Sponsor's protocol ID
- Omni-Pain-103
- Other IDs
- R44DA046316
- Status last verified
- Mar 2023
- First submitted
- 21 Dec 2020
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zebala JA, Searle SL, Webster LR, Johnson MS, Schuler AD, Maeda DY, Kahn SJ. Desmetramadol Has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials. J Pain. 2019 Oct;20(10):1218-1235. doi: 10.1016/j.jpain.2019.04.005. Epub 2019 Apr 18.
PubMed 31005596
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized Single Oral Dose Cross-Over Study Investigating Desmetramadol Dose Proportionality And Food Effect In Normal Human Subjects
- ClinicalTrials.gov ID
- NCT04683926
- Acronym / sponsor ID
- Omni-Pain-103
- Conditions
- Pain
- Keywords
- Pharmacokinetics, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Syntrix Biosystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion, National Institute on Drug Abuse (NIDA)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 4 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate in healthy human subjects how much desmetramadol (Omnitram) gets in the blood after different oral doses are taken with or without food.
Detailed description
An open-label, randomized, balanced, single-dose, four-treatment, four-period, four-sequence (using a Williams' square design) cross-over study with each dose separated by >3 days. There are 4 sequences (Sequence 1, Sequence 2, Sequence 3, and Sequence 4), and 4 Periods (Period I, Period II, Period III, and Period IV). Sequence 1 order is 30 mg dose with food (Period I); 30 mg dose fasted (Period II), 10 mg dose fasted (Period III), and 20 mg dose fasted (Period IV). Sequence 2 order is 10 mg dose fasted (Period I); 30 mg dose with food (Period II), 20 mg dose fasted (Period III), and 30 mg dose fasted (Period IV). Sequence 3 order is 20 mg dose fasted (Period I); 10 mg dose fasted (Period II), 30 mg dose fasted (Period III), and 30 mg dose with food (Period IV). Sequence 4 order is 30 mg dose fasted (Period I); 20 mg dose fasted (Period II), 30 mg dose with food (Period III), and 10 mg dose fasted (Period IV).
To account for potential dropouts, up to 32 eligible subjects will be randomized to obtain a target sample of 24 subjects with PK responses at each of the four treatment periods (based on our completed phase 1 study in 43 subjects, dropouts are unlikely (~5%); see Section 1.2.2). Before each oral dose, subjects will be fasted overnight for at least 10 hours. Treatment sequences will include the following four unblinded single-dose oral treatments: 1) desmetramadol 1 x 10 mg tablet; 2) desmetramadol 2 x 10 mg tablets; 3) desmetramadol 3 x 10 mg tablets; and 4) desmetramadol 3 x 10 mg tablets following a high-fat, high-calorie breakfast served approximately 30 minutes before dosing and entirely consumed within 20 minutes. All subjects will fast for an additional four hours after desmetramadol administration. The fed treatment should be administered the desmetramadol dose approximately 30 minutes after the start of the meal. Desmetramadol will be administered with approximately 240 ml of water. No water is allowed one hour before and one hour after each desmetramadol administration.
This will be an inpatient study. Subjects will be admitted to the clinical pharmacology unit on Study Day -1, and administered a single oral dose treatment on Study Day 1, Study Day 4, Study Day 7 and Study Day 10. After completing study procedures on Day 11 the subject will be discharged from the facility.
Blood specimens for plasma preparation and PK analysis will be collected at the following times: pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, and 32 h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- An open-label, randomized, balanced, single-dose, four-treatment, four-period, four-sequence (using a Williams' square design) cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Desmetramadol 10 mg, fasted | Experimental | Drug: DesmetramadolWhile fasting a single oral dose of 10 mg desmetramadol under. |
| Desmetramadol 20 mg, fasted | Experimental | Drug: DesmetramadolWhile fasting a single oral dose of 20 mg desmetramadol. |
| Desmetramadol 30 mg , fasted | Experimental | Drug: DesmetramadolWhile fasting a single oral dose of 30 mg desmetramadol. |
| Desmetramadol 30 mg , fed | Experimental | Drug: DesmetramadolAfter feeding a single oral dose of 30 mg desmetramadol. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy males and females with vital signs as follows at screening: systolic blood pressure > 90 mm Hg and < 140 mm Hg; diastolic blood pressure > 40 mm Hg and < 90 mm Hg; pulse 40 to 99 beats per minute; respiratory rate 12 to 24 breathes per minute.
- Age 19 to 55 years.
- Able and willing to give informed consent
- Able to comply with all study procedures.
- If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception from screening, throughout the study and for 30 days following study drug administration: hormonal (e.g., oral, transdermal, intravaginal, implant or injection for 3 months); double barrier (e.g., condom or diaphragm with spermicide); intrauterine device (IUD) or system (IUS) (for 3 months); vasectomized partner (6 months minimum); or abstinence.
Key exclusion criteria (12 listed)
- Oral temperature > 38°C or current illness.
- History of seizures, epilepsy, or recognized increase risk of seizure (e.g., head trauma, metabolic disorders, alcohol or drug withdrawal).
- History of cirrhosis or laboratory evidence of liver disease.
- Having undergone gall bladder removal.
- Use of alcohol within 24 hours of day -1 until the end of the study; and grapefruit, grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), or grapefruit juice or grapefruit-related juices within 7 days of study drug administration and until the end of the study.
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 |
|---|---|---|
| DesmetramadolAlso: OmnitramAnalgesic | Drug | Desmetramadol 10 mg, fasted, Desmetramadol 20 mg, fasted, Desmetramadol 30 mg , fasted, Desmetramadol 30 mg , fed |
Primary outcome
(-/+)-M1, AUC(0-32) and AUC(Inf)
Time frame: Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.
The AUC(0-32) and AUC(inf) of (-/+)-M1 after each treatment (i.e., 10, 20 and 30 mg desmetramadol fasted, and 30 mg desmetramadol fed)
(-/+)-M1, Cmax
Time frame: Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.
The Cmax of (-/+)-M1 after each treatment (i.e., 10, 20 and 30 mg desmetramadol fasted, and 30 mg desmetramadol fed)
1 secondary outcome
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time frame: Participant report adverse events throughout study enrolment; investigators observe adverse events during all 11 days of inpatient treatment; laboratory safety labs are obtained on Day 11 (the final study day).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31005596Zebala JA, Searle SL, Webster LR, Johnson MS, Schuler AD, Maeda DY, Kahn SJ. Desmetramadol Has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials. J Pain. 2019 Oct;20(10):1218-1235. doi: 10.1016/j.jpain.2019.04.005. Epub 2019 Apr 18.
- 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. This study is not recruiting at the moment.
Robert Schwab, MD principal investigator
Celerion
Stuart Kahn, MD study director
Syntrix Biosystems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Desmetramadol in people with Pain, run by Syntrix Biosystems, Inc. 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 13 inclusion and 12 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: finished, as of the sponsor's last update on 4 Apr 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(-/+)-M1, AUC(0-32) and AUC(Inf) (time frame: Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.). 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?
On the ClinicalTrials.gov record for NCT04683926, which also lists 1 linked publication.
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 4 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.