Pain, AcutePhase 1NCT02083315
Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
A Phase 1 study testing TRV130 1.5 mg, TRV130 3 mg and TRV130 4.5 mg in people with Pain, Acute, run by Trevena Inc. at 1 site in United States.
Trial summary
This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- TRV130 1.5 mg, TRV130 3 mg and TRV130 4.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2013
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
- Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2
- Acceptable duration of cold pain test results at screening
Who cannot join
- Clinically significant medical illness or physical exam findings
- Active dermatological conditions or skin trauma on the non-dominant hand, or peripheral vascular disease
- Partial blindness, keratoconus, nystagmus or any other ophthalmic condition which could interfere with pupillometry
- Use of tobacco or nicotine within 6 months prior to screening
- History of recent (within 6 months) drug or alcohol abuse, as defined in DSM-IV-TR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Explore the Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Adult Male Subjects
This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.
Read the detailed description
This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.
- Conditions
- Pain, Acute
- Being tested
- TRV130 1.5 mg, TRV130 3 mg, TRV130 4.5 mg, Morphine 10 mg, Placebo
- Keywords
- acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRV130 1.5 mgDrug
TRV130 1.5 mg IV x 1 dose
TRV130 3 mgDrug
TRV130 3 mg IV x 1 dose
TRV130 4.5 mgDrug
TRV130 4.5 mg IV x 1 dose
Morphine 10 mgDrug
Morphine 10 mg IV x 1 dose
PlaceboDrug
Dextrose 5% in water IV x 1 dose
| Study group | Role | What they receive |
|---|---|---|
| TRV130 1.5 mg | Experimental | TRV130 1.5 mg IV x 1 dose Receives: Drug: TRV130 1.5 mg |
| TRV130 3 mg | Experimental | TRV130 3 mg IV x 1 dose Receives: Drug: TRV130 3 mg |
| TRV130 4.5 mg | Experimental | TRV130 4.5 mg IV x 1 dose Receives: Drug: TRV130 4.5 mg |
| Morphine | Active comparator | Morphine 10 mg IV x 1 dose Receives: Drug: Morphine 10 mg |
| Placebo | Placebo comparator | Dextrose 5% in water IV x 1 dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold Pain Test
Measured: 8 hours postdose
Secondary outcomes (2)
Ventilatory Response to Hypercapnia
Measured: 4 hours postdose
Pupillometry
Measured: 8 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
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 Pain, AcuteStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevena Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G Soergel, MD, Study chair, Trevena Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083315
- Sponsor's protocol ID
- CP130-1003
- Status last verified
- Mar 2014
- First submitted
- 24 Feb 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Soergel DG, Subach RA, Burnham N, Lark MW, James IE, Sadler BM, Skobieranda F, Violin JD, Webster LR. Biased agonism of the mu-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014 Sep;155(9):1829-1835. doi: 10.1016/j.pain.2014.06.011. Epub 2014 Jun 19.
PubMed 24954166
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Explore the Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02083315
- Acronym / sponsor ID
- CP130-1003
- Conditions
- Pain, Acute
- Keywords
- acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Trevena Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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.
This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.
Detailed description
This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TRV130 1.5 mg | Experimental | Drug: TRV130 1.5 mgTRV130 1.5 mg IV x 1 dose |
| TRV130 3 mg | Experimental | Drug: TRV130 3 mgTRV130 3 mg IV x 1 dose |
| TRV130 4.5 mg | Experimental | Drug: TRV130 4.5 mgTRV130 4.5 mg IV x 1 dose |
| Morphine | Active comparator | Drug: Morphine 10 mgMorphine 10 mg IV x 1 dose |
| Placebo | Placebo comparator | Drug: PlaceboDextrose 5% in water IV x 1 dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed consent
- Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2
- Acceptable duration of cold pain test results at screening
Key exclusion criteria (5 listed)
- Clinically significant medical illness or physical exam findings
- Active dermatological conditions or skin trauma on the non-dominant hand, or peripheral vascular disease
- Partial blindness, keratoconus, nystagmus or any other ophthalmic condition which could interfere with pupillometry
- Use of tobacco or nicotine within 6 months prior to screening
- History of recent (within 6 months) drug or alcohol abuse, as defined in DSM-IV-TR
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 |
|---|---|---|
| TRV130 1.5 mgTRV130 1.5 mg IV x 1 dose | Drug | TRV130 1.5 mg |
| TRV130 3 mgTRV130 3 mg IV x 1 dose | Drug | TRV130 3 mg |
| TRV130 4.5 mgTRV130 4.5 mg IV x 1 dose | Drug | TRV130 4.5 mg |
| Morphine 10 mgMorphine 10 mg IV x 1 dose | Drug | Morphine |
| PlaceboDextrose 5% in water IV x 1 dose | Drug | Placebo |
Primary outcome
Cold Pain Test
Time frame: 8 hours postdose
2 secondary outcomes
Ventilatory Response to Hypercapnia
Time frame: 4 hours postdose
Pupillometry
Time frame: 8 hours postdose
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 11 Mar 2014.
- Derived from this study: PubMed 24954166Soergel DG, Subach RA, Burnham N, Lark MW, James IE, Sadler BM, Skobieranda F, Violin JD, Webster LR. Biased agonism of the mu-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014 Sep;155(9):1829-1835. doi: 10.1016/j.pain.2014.06.011. Epub 2014 Jun 19.
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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.
David G Soergel, MD study chair
Trevena Inc.
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 TRV130 1.5 mg, TRV130 3 mg and TRV130 4.5 mg in people with Pain, Acute, run by Trevena 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 3 inclusion and 5 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 11 Mar 2014. 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 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?
Cold Pain Test (time frame: 8 hours postdose). 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 NCT02083315, 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 11 Mar 2014.