BridgeMD
A study investigating the pain-relieving effects of a new drug in healthy adults
EU CTIS ID: 2022-501804-80-00
What this study is testing
To evaluate the analgesic effects of TRV045 using PainCart (including UVB burn inflammatory model)
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects between ≥ 18 and ≤ 55 years of age.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
- Females of childbearing potential must agree to use highly effective method of contraception surgical sterilization (e.g., bilateral tubal ligation), or any 2 barrier methods (a combination of male condom and female condom with diaphragm, sponge, cervical cap or intrauterine device [IUD], hormonal contraception) from screening through 180 days after administration of the last dose of investigational product (IP).The combination of a male condom and female condom only is not allowed.
- Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days, after administration of the last dose of IP, and their partners must be willing to use a highly effective method of contraception (e.g., IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant, or tubal ligation) from screening through 90 days after administration of the last dose of IP.
- Subjects must agree to not donate sperm from screening through 90 days, after administration of the last dose of IP.
You likely can't join if
- History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of a significant respiratory condition (e.g., asthma, chronic obstructive pulmonary disease [COPD], chronic sinusitis, or bronchitis).
- History or presence of conditions (including active viral or bacterial infection) that may place the subject at increased risk as determined by the investigator.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study involvement period.
- History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.