ICON plc. Van Swietenlaan 6
Groningen, 9728 NZ, Netherlands
NCT Number: NCT06877624
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
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. Approximately 24 healthy participants will be enrolled in a 3-formulation, 4-period, 6-sequence crossover study design to evaluate the PK characteristics of three formulations of QRL-101.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This cross-over design study will evaluate three formulations (Formulations 1, 2, and 3) of QRL-101, beginning in a fasted condition before moving to a fed cross-over design.
Time frame: Baseline through Follow up (Day 9)
The area under the curve to infinity
Time frame: Baseline through Follow up (Day 9)
The area under the curve to the last measurable time point
Time frame: Baseline through Follow up (Day 9)
Maximum concentration observed
Time frame: Baseline through Follow up (Day 9)
Trough level concentration for defined dose regimen
Time frame: Baseline through Follow up (Day 9)
The time to peak drug concentration
Time frame: Baseline through Follow up (Day 9)
Adverse events (AEs) and serious adverse events (SAEs)
QurAlis Corporation
Industry
A Randomized, Open-Label, Single Dose, Cross-Over Study 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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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