Recent Updates
Recently added Catalysts

Radiolabeled TRV130

Phase 1

Healthy | Small molecule | Other |Trevena, Inc.|Last Updated: Nov 18, 2015

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Radiolabeled TRV130 · 1 trial · 1 indication

Phase 1 1
NCT02169934A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male SubjectsHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
Day 1 - Day 13
To determine plasma concentrations of total radioactivity
Day 1 - Day 13
To determine whole blood concentrations of total radioactivity
Day 1 - Day 13
To determine urine concentrations of total radioactivity
Day 1 - Day 13
To determine fecal concentration of total radioactivity
Day 1 - Day 13

Secondary Endpoints

To identify metabolites associated with TRV130 in blood, urine and feces
Day 1 - Day 13
Number of patients experiencing an Adverse Event
Day 1 - Day 13
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Radiolabeled TRV130EXPERIMENTAL -

Interventions

NameTypeDescription
Radiolabeled TRV130DRUGA single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * 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 fo...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Radiolabeled TRV130

What is Radiolabeled TRV130?

Radiolabeled TRV130 is an investigational small molecule being developed by Trevena, Inc. It is a carbon-14 labeled version of TRV130, used to study the metabolism and excretion of the drug in healthy male subjects. It is currently in Phase 1 clinical development.

What is Radiolabeled TRV130 used for?

Radiolabeled TRV130 is used to investigate the metabolism and excretion of TRV130 in healthy male subjects. It is a radiolabeled form of the drug that allows researchers to track how the compound is processed and eliminated from the body. It is not intended for therapeutic use.

Who makes Radiolabeled TRV130?

Radiolabeled TRV130 is developed by Trevena, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TRVN. The company is conducting clinical research on this compound to understand its pharmacokinetic properties.

What phase is Radiolabeled TRV130 in?

Radiolabeled TRV130 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized study in healthy volunteers. The drug is investigational and has not been approved for any therapeutic use.

What clinical trials is Radiolabeled TRV130 in?

Radiolabeled TRV130 has been studied in one completed clinical trial, NCT02169934, titled "A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects." This Phase 1 trial enrolled 6 healthy male participants in the United States.