Healthy
Conditions
Keywords
Healthy, Pharmacodynamics (PD), Pharmacokinetics (PK)
Brief 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.
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.
Interventions
DRUGOpen-label TRV734 125 mg
125 mg
DRUGTRV734 blinded
blinded, multiple ascending dose
DRUGOxycodone IR 10 mg
DRUGPlacebo
TRV734-matched and oxycodone placebo
Sponsors
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734 | 4 days | Change from baseline in: Pupillometry and Cold Pain Test |
| Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734 | 4 days | 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. |
| Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms | 7 days | Change from baseline in: Pupillometry and Cold Pain Test |
| Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms. | 7 days | 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. |
Countries
United States
Outcome results
None listed