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NCT02211625 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, PD and PK Study in Healthy Adults
A Phase 1 study of Healthy, sponsored by Trevena.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT02211625: Completed Phase 1 study of Healthy, sponsored by Trevena.
NCT02211625 is a Phase 1 study of Healthy that has completed, run by Trevena. The registered enrollment target is 75 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02211625, a Phase 1 study of Healthy, has completed, sponsored by Trevena.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Open-label TRV734 125 mg
- DRUG TRV734 blinded
- DRUG Oxycodone IR 10 mg
Study Locations (1)
Texas
- ICON Development Solutions - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT02211625 record still lists
NCT02211625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02211625 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02211625 about?
NCT02211625 is a clinical study titled "A Safety, Tolerability, PD and PK Study in Healthy Adults". 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.
What is the current status of trial NCT02211625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2014-07. Estimated completion is 2014-10.
What conditions does trial NCT02211625 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02211625?
The interventions under investigation include: Placebo (DRUG), Open-label TRV734 125 mg (DRUG), TRV734 blinded (DRUG), Oxycodone IR 10 mg (DRUG).
Who is sponsoring clinical trial NCT02211625?
This trial is sponsored by Trevena, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02211625 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02211625's enrollment target sits among peer trials
75 300th of 1090 higher than 781 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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