Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Trevena Inc.
Age
18–55
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Healthy as determined by a responsible physician or trained qualified designee
Males: 18 - 55 years inclusive at screening
Capable of giving written informed consent
You may not be if
Clinically significant conditions or history of fainting or syncope
Medical or psychiatric illness that could interfere with the completion of treatment and follow up
Major surgery within 4-weeks of screening
Known difficulty with obtaining intravenous access
History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
Use of prescription or non-prescription medications
History of excessive alcohol use
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 4 weeks prior to dosing
Participation in a clinical trial and has received 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
Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
Clareo Health | A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
