HealthyPhase 1NCT02211625
A Safety, Tolerability, PD and PK Study in Healthy Adults
A Phase 1 study testing Open-label TRV734 125 mg, TRV734 blinded and Oxycodone IR 10 mg 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 safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Open-label TRV734 125 mg, TRV734 blinded and Oxycodone IR 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible physician or trained qualified designee
- Males (Part A) or males and females (Part B) between 18 \& 64 years of age, inclusive. Females must be of non-childbearing
- Capable of giving written informed consent
Who cannot join
- Clinically significant conditions, or history of fainting or syncope
- Medical or psychiatric illness
- Major surgery within 4 weeks of screening
- Known difficulty with obtaining intravenous access
- Any ophthalmologic condition that could interfere with pupillometry
- History of sensitivity to any of the investigational products, or known intolerance to opioids or a history of medication or other allergy
Show all 19Show fewer
- Use of prescription or non prescription medications
- 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 within 4 weeks prior to dosing
- Participation in a clinical trial and has received a 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
- If male, unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of childbearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
- Part B Only:
- Active dermatological condition or eczema on non-dominant hand.
- Peripheral vascular disease
- If female, of child bearing potential, pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Development Solutions
San Antonio, Texas, 78209
About this study
Official title: A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects
The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
Read the detailed description
This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers.
- Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal.
- Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double blind, double dummy, randomized, active- and placebo-controlled, adaptive study. Oxycodone immediate release (IR) 10 mg will be used as a benchmark.
- Conditions
- Healthy
- Being tested
- Open-label TRV734 125 mg, TRV734 blinded, Oxycodone IR 10 mg, Placebo
- Keywords
- Healthy, Pharmacodynamics (PD), Pharmacokinetics (PK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-label TRV734 125 mgDrug
125 mg
TRV734 blindedDrug
blinded, multiple ascending dose
Oxycodone IR 10 mgDrug
PlaceboDrug
TRV734-matched and oxycodone placebo
| Study group | Role | What they receive |
|---|---|---|
| TRV734 125 mg | Experimental | Part A, open-label will evaluate the the safety, PK and PD profile of a 125mg dose of TRV734 in which subjects are fasted, fed a standard meal, or fed a high-fat meal. Part A will also inform the dosing paradigm for Part B. Receives: Drug: Open-label TRV734 125 mg |
| Multiple ascending dose study, active and placebo comparators | Active comparator | Part B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo. Receives: Drug: TRV734 blinded; Drug: Oxycodone IR 10 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.
Measured: 7 days
Secondary outcomes (4)
Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734
Change from baseline in: Pupillometry and Cold Pain Test
Measured: 4 days
Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734
From the plasma concentration-time data, the following PK parameters will be determined, as data permit: AUC, Cmax, tmax, t½,eff, Vss/F, C, AR, and CL/F. From the urine concentration data, the following will PK parameters will be determined, as data permit: %UR and CLR.
Measured: 4 days
Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms
Change from baseline in: Pupillometry and Cold Pain Test
Measured: 7 days
Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms.
From the plasma concentration-time data, the following PK parameters will be determined, as data permit: AUC, Cmax, tmax, t½,eff, Vss/F, C, AR, and CL/F. From the urine concentration data, the following will PK parameters will be determined, as data permit: %UR and CLR.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevena Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franck Skobieranda, MD, Study director, Trevena Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211625
- Sponsor's protocol ID
- CP734-1002
- Status last verified
- Dec 2014
- First submitted
- 29 Jul 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02211625
- Acronym / sponsor ID
- CP734-1002
- Conditions
- Healthy
- Keywords
- Healthy, Pharmacodynamics (PD), Pharmacokinetics (PK)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Trevena Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Aug 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 primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
Detailed description
This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers.
- Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal.
- Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double blind, double dummy, randomized, active- and placebo-controlled, adaptive study. Oxycodone immediate release (IR) 10 mg will be used as a benchmark.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRV734 125 mg | Experimental | Drug: Open-label TRV734 125 mgPart A, open-label will evaluate the the safety, PK and PD profile of a 125mg dose of TRV734 in which subjects are fasted, fed a standard meal, or fed a high-fat meal. Part A will also inform the dosing paradigm for Part B. |
| Multiple ascending dose study, active and placebo comparators | Active comparator | Drug: TRV734 blinded, Drug: Oxycodone IR 10 mg, Drug: PlaceboPart B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy as determined by a responsible physician or trained qualified designee
- Males (Part A) or males and females (Part B) between 18 \& 64 years of age, inclusive. Females must be of non-childbearing
- Capable of giving written informed consent
Key exclusion criteria (19 listed)
- Clinically significant conditions, or history of fainting or syncope
- Medical or psychiatric illness
- Major surgery within 4 weeks of screening
- Known difficulty with obtaining intravenous access
- Any ophthalmologic condition that could interfere with pupillometry
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 |
|---|---|---|
| Open-label TRV734 125 mg125 mg | Drug | TRV734 125 mg |
| TRV734 blindedblinded, multiple ascending dose | Drug | Multiple ascending dose study, active and placebo comparators |
| Oxycodone IR 10 mg | Drug | Multiple ascending dose study, active and placebo comparators |
| PlaceboTRV734-matched and oxycodone placebo | Drug | Multiple ascending dose study, active and placebo comparators |
Primary outcome
Safety
Time frame: 7 days
Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.
4 secondary outcomes
Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734
Time frame: 4 days
Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734
Time frame: 4 days
Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms
Time frame: 7 days
Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms.
Time frame: 7 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 5 Dec 2014.
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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.
Franck Skobieranda, MD 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 Open-label TRV734 125 mg, TRV734 blinded and Oxycodone IR 10 mg 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 19 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 5 Dec 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. 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?
Safety (time frame: 7 days). 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 5 Dec 2014.