Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males
NCT ID: NCT01514578
Last Updated: 2012-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2012-01-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TRV130A
TRV130A
Intravenous infusion of 1 hour duration
Dextrose in Water
Dextrose in Water
Intravenous infusion of 1 hour duration
Interventions
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TRV130A
Intravenous infusion of 1 hour duration
Dextrose in Water
Intravenous infusion of 1 hour duration
Eligibility Criteria
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Inclusion Criteria
* Body weight \>/= 50 kg
* Capable of giving written informed consent
Exclusion Criteria
* Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine
* Major surgery within 4 weeks of screening
19 Years
50 Years
MALE
Yes
Sponsors
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Trevena Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David G. Soergel, MD
Role: STUDY_DIRECTOR
Trevena Inc.
Alan S. Marion, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ICON Development Solutions
Locations
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ICON Development Solutions
Omaha, Nebraska, United States
Countries
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References
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Soergel DG, Subach RA, Sadler B, Connell J, Marion AS, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014 Mar;54(3):351-7. doi: 10.1002/jcph.207. Epub 2014 Jan 28.
Soergel DG, Subach RA, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV027: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2013 Sep;53(9):892-9. doi: 10.1002/jcph.111. Epub 2013 Jun 29.
Other Identifiers
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CP130-1001
Identifier Type: -
Identifier Source: org_study_id