Actively Recruiting
A Multicenter Open-Label Treatment Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Led by Palvella Therapeutics, Inc. · Updated on 2022-12-09
45
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and pharmacokinetics of QTORIN rapamycin 3.9% anhydrous gel, called PTX-022, in adults with Pachyonychia Congenita (PC) who have specific keratin gene mutations and who previously participated in the PALV-05 (VAPAUS) trial. This open-label treatment study is conducted at multiple centers to better understand long-term exposure effects of the gel in this patient group. Participants receive the study drug PTX-022 applied as a gel, with the research focusing on monitoring safety and how the drug moves through and is processed by the body over time. The study does not have a placebo group or masking, and treatment details are based on prior enrollment and dosing established in earlier trials. Participants are monitored for treatment-emergent adverse events over six months, with pharmacokinetic measurements taken before dosing and at 12 and 24 hours after application. The trial assesses drug safety and how the body absorbs and metabolizes the gel during this period, helping researchers understand long-term use implications.
CONDITIONS
Brief Title
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed the PALV-05 (VAPAUS) study
- Agree to contraceptive use
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical)
- Any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study
- Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants apply QTORIN rapamycin 3.9% anhydrous gel as part of the study treatment.
Visits prior to dose, and at 12 hours and 24 hours after dosing for pharmacokinetic assessments
Trial Site Locations
Total: 1 location
1
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
Actively Recruiting
Research Team
E
Emily Cook
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here