HealthyPhase 1NCT02169934
A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects
A Phase 1 study testing Radiolabeled TRV130 in people with Healthy, run by Trevena Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the routes of excretion for TRV130 and it's metabolites, and to determine and characterize, structurally, the metabolites present in plasma, urine, and feces in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Radiolabeled TRV130
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2015
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, between 18 and 64 years of age, inclusive
- With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- Negative test for selected drugs of abuse at Screening and at Check-in
- Able to comprehend and willing to sign an Informed Consent Form (ICF) prior to any study procedure
- A typical minimum of 1 to 2 bowel movements per day
Who cannot join
- History of sensitivity to any of the study medications or components thereof or a history of medication or other allergy that, in the opinion of the Investigator, contraindicates their participation
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days prior to Check-in
- Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
- Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
- Has current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and fully excised in a curative procedure);
- Use of any tobacco- or nicotine-containing products within 6 months prior to Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Madison Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects
The purpose of this study is to determine the routes of excretion for TRV130 and it's metabolites, and to determine and characterize, structurally, the metabolites present in plasma, urine, and feces in healthy male subjects.
Read the detailed description
This study is an open-label, non-randomized, metabolism and excretion study of a single 2 mg IV dose of [14C] TRV130 (approximately 100 µCi) administered as a 10 mL manual IV push over 2 minutes in a fasted state.
- Conditions
- Healthy
- Being tested
- Radiolabeled TRV130
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabeled TRV130Drug
A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Radiolabeled TRV130 | Experimental | Not described Receives: Drug: Radiolabeled TRV130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
Measured: Day 1 - Day 13
To determine plasma concentrations of total radioactivity
Measured: Day 1 - Day 13
To determine whole blood concentrations of total radioactivity
Measured: Day 1 - Day 13
To determine urine concentrations of total radioactivity
Measured: Day 1 - Day 13
To determine fecal concentration of total radioactivity
Measured: Day 1 - Day 13
Secondary outcomes (2)
To identify metabolites associated with TRV130 in blood, urine and feces
Measured: Day 1 - Day 13
Number of patients experiencing an Adverse Event
Measured: Day 1 - Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevena Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trevena Inc, Study director, Trevena Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169934
- Sponsor's protocol ID
- CP130-1007
- Status last verified
- Nov 2015
- First submitted
- 17 Jun 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02169934
- Acronym / sponsor ID
- CP130-1007
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Trevena Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jun 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.
The purpose of this study is to determine the routes of excretion for TRV130 and it's metabolites, and to determine and characterize, structurally, the metabolites present in plasma, urine, and feces in healthy male subjects.
Detailed description
This study is an open-label, non-randomized, metabolism and excretion study of a single 2 mg IV dose of [14C] TRV130 (approximately 100 µCi) administered as a 10 mL manual IV push over 2 minutes in a fasted state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiolabeled TRV130 | Experimental | Drug: Radiolabeled TRV130 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males, between 18 and 64 years of age, inclusive
- With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- Negative test for selected drugs of abuse at Screening and at Check-in
- Able to comprehend and willing to sign an Informed Consent Form (ICF) prior to any study procedure
Key exclusion criteria (6 listed)
- History of sensitivity to any of the study medications or components thereof or a history of medication or other allergy that, in the opinion of the Investigator, contraindicates their participation
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days prior to Check-in
- Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
- Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
- Has current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and fully excised in a curative procedure);
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 |
|---|---|---|
| Radiolabeled TRV130A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes | Drug | Radiolabeled TRV130 |
Primary outcome
To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
Time frame: Day 1 - Day 13
To determine plasma concentrations of total radioactivity
Time frame: Day 1 - Day 13
To determine whole blood concentrations of total radioactivity
Time frame: Day 1 - Day 13
To determine urine concentrations of total radioactivity
Time frame: Day 1 - Day 13
To determine fecal concentration of total radioactivity
Time frame: Day 1 - Day 13
2 secondary outcomes
To identify metabolites associated with TRV130 in blood, urine and feces
Time frame: Day 1 - Day 13
Number of patients experiencing an Adverse Event
Time frame: Day 1 - Day 13
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 18 Nov 2015.
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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.
Trevena Inc study director
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 Radiolabeled TRV130 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 6 inclusion and 6 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 18 Nov 2015. 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?
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?
To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130 (time frame: Day 1 - Day 13). The study lists 5 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 18 Nov 2015.