Status:
COMPLETED
A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants
Lead Sponsor:
QurAlis Corporation
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the pharmacokinetics of three QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.
Detailed Description
This is a randomized, open-label, single-dose, crossover study to evaluate the PK of three formulations of QRL-101 beginning in a fasted condition before moving to a fed cross-over design. Approximate...
Eligibility Criteria
Inclusion
- Age 18 to 70 years of age inclusive at the time of signing the informed consent.
- Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
- Body mass index of 18 to 32 kg/m2 (inclusive).
- Willing and able to practice effective contraception.
Exclusion
- Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
- History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06877624
Start Date
January 10 2025
End Date
May 15 2025
Last Update
August 26 2025
Active Locations (1)
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1
ICON plc. Van Swietenlaan 6
Groningen, Netherlands, 9728 NZ