PainPhase 1NCT05491785
Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain.
A Phase 1 study testing Cebranopadol 600 µg, Cebranopadol 800 µg and Cebranopadol 1000 µg in people with Pain, run by Tris Pharma, Inc. at 2 sites in Netherlands.
Trial summary
Opioids are potent painkillers but come with serious adverse effects ranging from addiction to potentially lethal respiratory depression via activation of μ-opioid receptors (MOP) at specific sites in the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Cebranopadol 600 µg, Cebranopadol 800 µg and Cebranopadol 1000 µg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 29 Jul 2022to 2 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed informed consent prior to any study-mandated procedure.
- Subject is able to speak, read, and understand Dutch and voluntarily provide written informed consent to participate in the study.
- Adult men or women aged 18 to 45 years, inclusive.
- Subjects are in good health as indicated by medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG.
- Body mass index between 18.0 kg/m2 and 32.0 kg/m2 and body weight greater than 50 kg, inclusive.
- Adequate contraception is being used or women of nonchildbearing potential may be enrolled if surgically sterile (i.e., after hysterectomy) or postmenopausal for at least 2 years (based on subject's report).
Who cannot join
- History or presence of clinically significant cardiovascular (incl. a history of risk factors for torsade de pointes e.g., heart failure, hypokalaemia, family history of long QT syndrome, history of myocardial infarction, ischaemic heart disease, clinically significant arrhythmia or uncontrolled arrhythmia or cardiac failure), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease (e.g., anxiety); or any other condition (e.g., hyperventilation disorder), which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- History of known difficult airway access or uncontrolled gastroesophageal reflux disease (GERD), gastric motility disorders, or delayed gastric emptying
- Has clinically significant abnormalities on ECG at screening or Day -1, as defined by the following:
- prolonged corrected QT interval (Fridericia-corrected QT interval [QTcF] >450 ms in males and >470 ms in females) demonstrated on ECG;
- Left bundle branch block at Screening or Baseline
- Systolic blood pressure (BP) >150 or <90 mmHg or diastolic BP >90 or <50 mmHg at Screening or Baseline, or history of clinically significant orthostatic hypotension.
Show all 22Show fewer
- Heart rate (HR) <40 beats per minute (bpm) or >100 bpm at Screening.
- Is currently enrolled in another clinical study or used any investigational drug or device within 3 months prior to dosing or has participated in more than 4 investigational drug studies within 1 year prior to Screening.
- Has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or has or is suspected of having paralytic ileus).
- Have a history of chronic obstructive pulmonary disease or any other lung disease (e.g., asthma, bronchitis, obstructive sleep apnoea, exercise-induced asthma) that would cause CO2 retention.
- History of opioid use disorder per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) classification, or other drug/substance or alcohol dependency or abuse (excluding nicotine and caffeine) within the last 5 years before Screening.
- Has a positive alcohol test or urine drug screen for drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, and opioids) at Screening or Day -1.
- Use of nicotine-containing products within 4 weeks before the Screening visit and not able to withhold from smoking during the study.
- Pregnant or breastfeeding.
- Subjects indicating pain test intolerability at Screening or achieving pain tolerance at >80% of maximum input intensity for the pain tests.
- Demonstrated allergic reactions (e.g., food, drug, atopic reactions, or asthmatic episodes) which, in the opinion of the Investigator, interfere with the subject's ability to participate in the trial.
- Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (Anti-HBc), hepatitis C antibodies (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at Screening.
- Use of prescription, non-prescription medications or herbal preparations containing St. John's Wort, within 14 days or 5 half-lives prior to dosing, whichever is longer. An exception is made for contraceptives and incidental use of paracetamol or ibuprofen, which is allowed up to 48 hours before start of each visit. Other exceptions are allowed only when clearly documented by the investigator.
- No vitamin, mineral, herbal, and dietary supplements will be permitted within 7 days prior to study drug administrations, or less than 5 half-lives (whichever is longer, and during the course of the study.
- Any clinically significant lifetime history of suicidal behaviour or ideation and/or poses a current (within the past 12 months) suicide risk, as assessed by scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening per Investigator judgment
- Receipt of blood products within 4 weeks, blood donation or blood loss >250 mL within 8 weeks, or donation of plasma within 1 week of any Study Drug dose administration.
- Is employed by Tris, Park, the Centre for Human Drug Research (CHDR), or the Investigator or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is immediate family* of a Tris, Park, CHDR, Investigator, or study site employee.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Centre for Human Drug Research (CHDR)
Leiden
Leiden University Medical Centre (LUMC)
Leiden
About this study
Official title: Randomized, Double-blind, Four Period, Six-treatment, Double-dummy, Placebo Controlled, Partial-crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH) of Cebranopadol, Oxycodone, and Placebo in Healthy Subjects
Opioids are potent painkillers but come with serious adverse effects ranging from addiction to potentially lethal respiratory depression via activation of μ-opioid receptors (MOP) at specific sites in the central nervous system. Cebranopadol is a first-in-class investigational drug to treat patients with acute and chronic pain. The molecule dually activates the Nociceptin/Orphanin FQ peptide (NOP) receptor and the classical MOP receptor. This is a unique mechanism of action and has demonstrated efficacy in multiple Phase 2 and Phase 3 clinical studies across several nociceptive and neuropathic indications as well as a superior safety profile, low potential for abuse and minimal risk of physical dependence. In animal studies, cebranopadol produced considerably less respiratory depression at comparably analgesic doses of oxycodone and fentanyl and appeared to have a ceiling to its respiratory effects. Preliminary clinical trials have suggested that these results will be similar in humans.
The present study is designed to investigate if: 1) cebranopadol produces less respiratory depression than oxycodone 2) cebranopadol respiratory effects have a ceiling at very high doses and 3) cebranopadol does not produce significant respiratory depression, as measured in this study design with 30 subjects, at any dose in the VRH model.
Read the detailed description
This is a randomized, double blind, four period, six-treatment, double-dummy, placebo controlled, partial-crossover study will investigate the effects of cebranopadol on the ventilatory response to hypercapnia (VRH), nociceptive thresholds and safety.
VRH testing is non-invasive and is an established technique to evaluate respiratory depression following the administration of opioids.
The test will be performed using a rebreathing setup with the subjects comfortably seated or semi-supine in a hospital bed and breathing through a facemask. VRH will be performed at several timepoints post-administration of cebranopadol, oxycodone or placebo in a randomized fashion. At each time point, subjects will be allowed an acclimation period of ambient air to establish regular breathing pattern; immediately followed by rebreathing a hypercapnic gas mixture (7%CO2, in oxygen (50%)), for at least 3 min. Between timepoints, subjects will remove their face masks and breathe ambient air.
- Conditions
- Pain
- Being tested
- Cebranopadol 600 µg, Cebranopadol 800 µg, Cebranopadol 1000 µg, Oxycodone 30 mg, Oxycodone 60 mg
- Keywords
- cebranopadol, pain, respiratory, hypercapnia
- Medical subject headings
- Pain, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cebranopadol 600 µgDrug
Also called Experimental
Participants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, 3 cebranopadol 200 µg tablets and 2 cebranopadol placebo tablets
Cebranopadol 800 µgDrug
Also called Experimental
Participants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, 4 cebranopadol 200 µg tablets and 1 cebranopadol placebo tablet
Cebranopadol 1000 µgDrug
Also called Experimental
Participants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, and 5 cebranopadol 200 µg tablets
Oxycodone 30 mgDrug
Also called Active Comparator
Participants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone 10 mg capsules, and 5 cebranopadol placebo tablets
Oxycodone 60 mgDrug
Also called Active Comparator
Participants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone 20 mg capsules, and 5 cebranopadol placebo tablets
PlaceboDrug
Also called Placebo comparator
Participants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, and 5 cebranopadol placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Cebranopadol 600 µg | Experimental | 3 x 200 µg cebranopadol tablets Receives: Drug: Cebranopadol 600 µg |
| Cebranopadol 800 µg | Experimental | 4 x 200 µg cebranopadol tablets Receives: Drug: Cebranopadol 800 µg |
| Cebranopadol 1000 µg | Experimental | 5 x 200 µg cebranopadol tablets Receives: Drug: Cebranopadol 1000 µg |
| Oxycodone 30 mg | Active comparator | 3 x 10 mg Oxycodone tablets Receives: Drug: Oxycodone 30 mg |
| Oxycodone 60 mg | Active comparator | 3 x 20 mg Oxycodone tablets Receives: Drug: Oxycodone 60 mg |
| Cebranopadol placebo tablets/ Oxycodone placebo capsules | Placebo comparator | Cebranopadol placebo tablets/ Oxycodone placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory response to hypercapnia (VRH) by maximum decrease in minute ventilation (L)
Pre-dose to 24 h postdose
Measured: 24 hours
Secondary outcomes (3)
Pupil constriction compared to baseline (mm)
Pre-dose to 24 h postdose
Measured: 24 hours
Electrical and pressure pain tests
Pre-dose to 24 h postdose
Measured: 24 hours
Adverse event reporting
Pre-dose to 24 h postdose
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start29 Jul 2022
- Primary completion30 Mar 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomized, double blind, four- period, six-treatment, double-dummy, placebo controlled, partial-crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Dahan, MD, PhD, Principal investigator, LUMCGeert Jan Groeneveld, MD, PhD, Principal investigator, CHDR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491785
- Sponsor's protocol ID
- PARK-104-VRH
- Status last verified
- May 2024
- First submitted
- 27 Jul 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dahan A, Boom M, Sarton E, Hay J, Groeneveld GJ, Neukirchen M, Bothmer J, Aarts L, Olofsen E. Respiratory Effects of the Nociceptin/Orphanin FQ Peptide and Opioid Receptor Agonist, Cebranopadol, in Healthy Human Volunteers. Anesthesiology. 2017 Apr;126(4):697-707. doi: 10.1097/ALN.0000000000001529.
PubMed 28291085
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Four Period, Six-treatment, Double-dummy, Placebo Controlled, Partial-crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH) of Cebranopadol, Oxycodone, and Placebo in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05491785
- Acronym / sponsor ID
- PARK-104-VRH
- Conditions
- Pain
- Keywords
- cebranopadol, pain, respiratory, hypercapnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 8 Aug 2022 (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.
Opioids are potent painkillers but come with serious adverse effects ranging from addiction to potentially lethal respiratory depression via activation of μ-opioid receptors (MOP) at specific sites in the central nervous system. Cebranopadol is a first-in-class investigational drug to treat patients with acute and chronic pain. The molecule dually activates the Nociceptin/Orphanin FQ peptide (NOP) receptor and the classical MOP receptor. This is a unique mechanism of action and has demonstrated efficacy in multiple Phase 2 and Phase 3 clinical studies across several nociceptive and neuropathic indications as well as a superior safety profile, low potential for abuse and minimal risk of physical dependence. In animal studies, cebranopadol produced considerably less respiratory depression at comparably analgesic doses of oxycodone and fentanyl and appeared to have a ceiling to its respiratory effects. Preliminary clinical trials have suggested that these results will be similar in humans.
The present study is designed to investigate if: 1) cebranopadol produces less respiratory depression than oxycodone 2) cebranopadol respiratory effects have a ceiling at very high doses and 3) cebranopadol does not produce significant respiratory depression, as measured in this study design with 30 subjects, at any dose in the VRH model.
Detailed description
This is a randomized, double blind, four period, six-treatment, double-dummy, placebo controlled, partial-crossover study will investigate the effects of cebranopadol on the ventilatory response to hypercapnia (VRH), nociceptive thresholds and safety.
VRH testing is non-invasive and is an established technique to evaluate respiratory depression following the administration of opioids.
The test will be performed using a rebreathing setup with the subjects comfortably seated or semi-supine in a hospital bed and breathing through a facemask. VRH will be performed at several timepoints post-administration of cebranopadol, oxycodone or placebo in a randomized fashion. At each time point, subjects will be allowed an acclimation period of ambient air to establish regular breathing pattern; immediately followed by rebreathing a hypercapnic gas mixture (7%CO2, in oxygen (50%)), for at least 3 min. Between timepoints, subjects will remove their face masks and breathe ambient air.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized, double blind, four- period, six-treatment, double-dummy, placebo controlled, partial-crossover study
| Arm | Type | Receives |
|---|---|---|
| Cebranopadol 600 µg | Experimental | Drug: Cebranopadol 600 µg3 x 200 µg cebranopadol tablets |
| Cebranopadol 800 µg | Experimental | Drug: Cebranopadol 800 µg4 x 200 µg cebranopadol tablets |
| Cebranopadol 1000 µg | Experimental | Drug: Cebranopadol 1000 µg5 x 200 µg cebranopadol tablets |
| Oxycodone 30 mg | Active comparator | Drug: Oxycodone 30 mg3 x 10 mg Oxycodone tablets |
| Oxycodone 60 mg | Active comparator | Drug: Oxycodone 60 mg3 x 20 mg Oxycodone tablets |
| Cebranopadol placebo tablets/ Oxycodone placebo capsules | Placebo comparator | Drug: PlaceboCebranopadol placebo tablets/ Oxycodone placebo capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent prior to any study-mandated procedure.
- Subject is able to speak, read, and understand Dutch and voluntarily provide written informed consent to participate in the study.
- Adult men or women aged 18 to 45 years, inclusive.
- Subjects are in good health as indicated by medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG.
- Body mass index between 18.0 kg/m2 and 32.0 kg/m2 and body weight greater than 50 kg, inclusive.
Key exclusion criteria (22 listed)
- History or presence of clinically significant cardiovascular (incl. a history of risk factors for torsade de pointes e.g., heart failure, hypokalaemia, family history of long QT syndrome, history of myocardial infarction, ischaemic heart disease, clinically significant arrhythmia or uncontrolled arrhythmia or cardiac failure), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease (e.g., anxiety); or any other condition (e.g., hyperventilation disorder), which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- History of known difficult airway access or uncontrolled gastroesophageal reflux disease (GERD), gastric motility disorders, or delayed gastric emptying
- Has clinically significant abnormalities on ECG at screening or Day -1, as defined by the following:
- Systolic blood pressure (BP) >150 or <90 mmHg or diastolic BP >90 or <50 mmHg at Screening or Baseline, or history of clinically significant orthostatic hypotension.
- Heart rate (HR) <40 beats per minute (bpm) or >100 bpm at 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 |
|---|---|---|
| Cebranopadol 600 µgAlso: ExperimentalParticipants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, 3 cebranopadol 200 µg tablets and 2 cebranopadol placebo tablets | Drug | Cebranopadol 600 µg |
| Cebranopadol 800 µgAlso: ExperimentalParticipants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, 4 cebranopadol 200 µg tablets and 1 cebranopadol placebo tablet | Drug | Cebranopadol 800 µg |
| Cebranopadol 1000 µgAlso: ExperimentalParticipants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, and 5 cebranopadol 200 µg tablets | Drug | Cebranopadol 1000 µg |
| Oxycodone 30 mgAlso: Active ComparatorParticipants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone 10 mg capsules, and 5 cebranopadol placebo tablets | Drug | Oxycodone 30 mg |
| Oxycodone 60 mgAlso: Active ComparatorParticipants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone 20 mg capsules, and 5 cebranopadol placebo tablets | Drug | Oxycodone 60 mg |
| PlaceboAlso: Placebo comparatorParticipants will be administered a single dose of 8 identically appearing capsules containing: 3 oxycodone placebo capsules, and 5 cebranopadol placebo tablets | Drug | Cebranopadol placebo tablets/ Oxycodone placebo capsules |
Primary outcome
Ventilatory response to hypercapnia (VRH) by maximum decrease in minute ventilation (L)
Time frame: 24 hours
Pre-dose to 24 h postdose
3 secondary outcomes
Pupil constriction compared to baseline (mm)
Time frame: 24 hours
Electrical and pressure pain tests
Time frame: 24 hours
Adverse event reporting
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 28291085Dahan A, Boom M, Sarton E, Hay J, Groeneveld GJ, Neukirchen M, Bothmer J, Aarts L, Olofsen E. Respiratory Effects of the Nociceptin/Orphanin FQ Peptide and Opioid Receptor Agonist, Cebranopadol, in Healthy Human Volunteers. Anesthesiology. 2017 Apr;126(4):697-707. doi: 10.1097/ALN.0000000000001529.
- 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.
Albert Dahan, MD, PhD principal investigator
LUMC
Geert Jan Groeneveld, MD, PhD principal investigator
CHDR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cebranopadol 600 µg, Cebranopadol 800 µg and Cebranopadol 1000 µg in people with Pain, run by Tris Pharma, Inc. at 2 sites in Netherlands.
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 6 inclusion and 22 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ventilatory response to hypercapnia (VRH) by maximum decrease in minute ventilation (L) (time frame: 24 hours). 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 NCT05491785, 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 9 May 2024.