HealthyPhase 1NCT01514578
Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males
A Phase 1 study testing TRV130A and Dextrose in Water in people with Healthy, run by Trevena Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TRV130A and Dextrose in Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2012
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male 19 - 50 years of age
- Body weight >/= 50 kg
- Capable of giving written informed consent
Who cannot join
- Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
- Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine
- Major surgery within 4 weeks of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TRV130A in Healthy Adult Males
This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.
- Conditions
- Healthy
- Being tested
- TRV130A, Dextrose in Water
- Keywords
- safety, tolerability, TRV130A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRV130ADrug
Intravenous infusion of 1 hour duration
Dextrose in WaterDrug
Intravenous infusion of 1 hour duration
| Study group | Role | What they receive |
|---|---|---|
| TRV130A | Experimental | Not described Receives: Drug: TRV130A |
| Dextrose in Water | Placebo comparator | Not described Receives: Drug: Dextrose in Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: Baseline to 8 days after dose administration
Area under the plasma concentration versus time curve of TRV130A
Measured: Baseline to 24 hours after dose administration
Secondary outcomes (4)
Effect of TRV130A on pain perception using cold pain test
Measured: Baseline to 3 hours after dose administration
Effect of TRV130A on pupil diameter
Measured: Baseline to 3 hours after dose administration
Effect of TRV130A on eye movements
Using saccadic eye movement measurement
Measured: Baseline to 3 hours after dose administration
Effect of TRV130A on sedation
Sedation evaluated by questionnaire
Measured: Baseline to 3 hours after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevena Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G. Soergel, MD, Study director, Trevena Inc.Alan S. Marion, MD, PhD, Principal investigator, ICON Development Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514578
- Sponsor's protocol ID
- CP130-1001
- Status last verified
- Aug 2012
- First submitted
- 17 Jan 2012
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Soergel DG, Subach RA, Sadler B, Connell J, Marion AS, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014 Mar;54(3):351-7. doi: 10.1002/jcph.207. Epub 2014 Jan 28.
PubMed 24122908Soergel DG, Subach RA, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV027: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2013 Sep;53(9):892-9. doi: 10.1002/jcph.111. Epub 2013 Jun 29.
PubMed 23813302
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TRV130A in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT01514578
- Acronym / sponsor ID
- CP130-1001
- Conditions
- Healthy
- Keywords
- safety, tolerability, TRV130A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Trevena Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Jan 2012 (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 will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRV130A | Experimental | Drug: TRV130A |
| Dextrose in Water | Placebo comparator | Drug: Dextrose in Water |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult male 19 - 50 years of age
- Body weight >/= 50 kg
- Capable of giving written informed consent
Key exclusion criteria (3 listed)
- Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
- Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine
- Major surgery within 4 weeks 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 |
|---|---|---|
| TRV130AIntravenous infusion of 1 hour duration | Drug | TRV130A |
| Dextrose in WaterIntravenous infusion of 1 hour duration | Drug | Dextrose in Water |
Primary outcome
Number of subjects with adverse events
Time frame: Baseline to 8 days after dose administration
Area under the plasma concentration versus time curve of TRV130A
Time frame: Baseline to 24 hours after dose administration
4 secondary outcomes
Effect of TRV130A on pain perception using cold pain test
Time frame: Baseline to 3 hours after dose administration
Effect of TRV130A on pupil diameter
Time frame: Baseline to 3 hours after dose administration
Effect of TRV130A on eye movements
Time frame: Baseline to 3 hours after dose administration
Effect of TRV130A on sedation
Time frame: Baseline to 3 hours after dose administration
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 24 Aug 2012.
- Derived from this study: PubMed 24122908Soergel DG, Subach RA, Sadler B, Connell J, Marion AS, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014 Mar;54(3):351-7. doi: 10.1002/jcph.207. Epub 2014 Jan 28.
- Derived from this study: PubMed 23813302Soergel DG, Subach RA, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV027: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2013 Sep;53(9):892-9. doi: 10.1002/jcph.111. Epub 2013 Jun 29.
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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 director
Trevena Inc.
Alan S. Marion, MD, PhD principal investigator
ICON Development Solutions
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 TRV130A and Dextrose in Water in people with Healthy, 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 3 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 24 Aug 2012. 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?
Number of subjects with adverse events (time frame: Baseline to 8 days after dose administration). 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 NCT01514578, which also lists 2 linked publications.
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 24 Aug 2012.