HealthyPhase 1NCT02411500
A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
A Phase 1 study testing TRV734 in people with Healthy, run by Trevena Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TRV734
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible physician or trained qualified designee
- Males: 18 - 55 years inclusive at screening
- Capable of giving written informed consent
Who cannot join
- Clinically significant conditions or history of fainting or syncope
- Medical or psychiatric illness that could interfere with the completion of treatment and follow up
- Major surgery within 4-weeks of screening
- Known difficulty with obtaining intravenous access
- History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
- Use of prescription or non-prescription medications
Show all 15Show fewer
- History of excessive alcohol use
- History of drug abuse within 6 months of screening
- Use of any illegal drug within 30 days of screening and throughout participation in the study
- History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
- Donation of blood or plasma 4 weeks prior to dosing
- Participation in a clinical trial and has received medication within 30 days
- Weight <50 kg or BMI outside range of 18-32 kg/m2
- Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
- Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects
The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.
- Conditions
- Healthy
- Being tested
- TRV734
- Keywords
- Healthy, Male, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRV734Drug
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | Not described Receives: Drug: TRV734 |
| Formulation B | Experimental | Not described Receives: Drug: TRV734 |
| Formulation C | Experimental | Not described Receives: Drug: TRV734 |
| Formulation D | Experimental | Not described Receives: Drug: TRV734 |
| Formulation E | Experimental | Not described Receives: Drug: TRV734 |
| Formulation F | Experimental | Not described Receives: Drug: TRV734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the maximum observed plasma concentration (Cmax)
Measured: 9-days
Evaluate the time at which the maximum plasma concentration was observed (tmax)
Measured: 9-days
Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)
Measured: 9-days
Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)
Measured: 9-days
Evaluate the apparent elimination half-life (t1/2)
Measured: 9-days
Evaluate the apparent clearance (CL/F)
Measured: 9-days
Secondary outcomes (7)
Safety and tolerability as measured by adverse events
Measured: 9-days
Safety and tolerability as measured by clinical observations
Measured: 9-days
Safety and tolerability as measured by 12-lead ECGs
Measured: 9-days
Safety and tolerability as measured by cardiac telemetry monitoring
Measured: 9-days
Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)
Measured: 9-days
Safety and tolerability as measured by oxygen saturation
Measured: 9-days
Safety and tolerability as measured by safety laboratory tests
Measured: 9-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevena Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411500
- Sponsor's protocol ID
- CP734-1003
- Status last verified
- Nov 2015
- First submitted
- 4 Mar 2015
- 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 Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02411500
- Acronym / sponsor ID
- CP734-1003
- Conditions
- Healthy
- Keywords
- Healthy, Male, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Trevena Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Apr 2015 (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 primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: TRV734 |
| Formulation B | Experimental | Drug: TRV734 |
| Formulation C | Experimental | Drug: TRV734 |
| Formulation D | Experimental | Drug: TRV734 |
| Formulation E | Experimental | Drug: TRV734 |
| Formulation F | Experimental | Drug: TRV734 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy as determined by a responsible physician or trained qualified designee
- Males: 18 - 55 years inclusive at screening
- Capable of giving written informed consent
Key exclusion criteria (15 listed)
- Clinically significant conditions or history of fainting or syncope
- Medical or psychiatric illness that could interfere with the completion of treatment and follow up
- Major surgery within 4-weeks of screening
- Known difficulty with obtaining intravenous access
- History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
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 |
|---|---|---|
| TRV734Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days. | Drug | Formulation A, Formulation B, Formulation C, Formulation D, Formulation E, Formulation F |
Primary outcome
Evaluate the maximum observed plasma concentration (Cmax)
Time frame: 9-days
Evaluate the time at which the maximum plasma concentration was observed (tmax)
Time frame: 9-days
Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)
Time frame: 9-days
Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)
Time frame: 9-days
Evaluate the apparent elimination half-life (t1/2)
Time frame: 9-days
Evaluate the apparent clearance (CL/F)
Time frame: 9-days
7 secondary outcomes
Safety and tolerability as measured by adverse events
Time frame: 9-days
Safety and tolerability as measured by clinical observations
Time frame: 9-days
Safety and tolerability as measured by 12-lead ECGs
Time frame: 9-days
Safety and tolerability as measured by cardiac telemetry monitoring
Time frame: 9-days
Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)
Time frame: 9-days
Safety and tolerability as measured by oxygen saturation
Time frame: 9-days
Safety and tolerability as measured by safety laboratory tests
Time frame: 9-days
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.
The record lists no contact. Use the official record to reach the sponsor.
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 TRV734 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 15 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?
Evaluate the maximum observed plasma concentration (Cmax) (time frame: 9-days). The study lists 6 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.