Clinical trial NCT06877624: A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: QurAlis Corporation
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized, open-label, single-dose, cross-over study to evaluate the pharmacokinetics of 3 QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 70 years of age inclusive at the time of signing the informed consent.
2. Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
3. Body mass index of 18 to 32 kg/m2 (inclusive).
4. Willing and able to practice effective contraception.

Exclusion Criteria:

1. 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.
2. Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
3. 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.

Primary outcomes:
measure: Plasma PK profile (AUCinf)
timeFrame: Baseline through Follow up (Day 9)
measure: Plasma PK profile (AUClast)
timeFrame: Baseline through Follow up (Day 9)
measure: Plasma PK profile (Cmax)
timeFrame: Baseline through Follow up (Day 9)
measure: Plasma PK profile (Ctrough)
timeFrame: Baseline through Follow up (Day 9)
measure: Plasma PK profile (Tmax)
timeFrame: Baseline through Follow up (Day 9)
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Baseline through Follow up (Day 9)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON plc. Van Swietenlaan 6
Study officials:
affiliation: ICON plc
name: Salah Hadi, MD
role: PRINCIPAL_INVESTIGATOR
References: