Healthy Volunteers
Conditions
Keywords
Healthy Volunteers
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.
Interventions
DRUGQRL-101
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.
Sponsors
QurAlis Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
A participant and investigator-blinded, randomized, open-label, single-dose, cross-over design will be used to minimize bias in this study.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PK profile (AUCinf) | Baseline through Follow up (Day 9) | The area under the curve to infinity |
| Plasma PK profile (AUClast) | Baseline through Follow up (Day 9) | The area under the curve to the last measurable time point |
| Plasma PK profile (Cmax) | Baseline through Follow up (Day 9) | Maximum concentration observed |
| Plasma PK profile (Ctrough) | Baseline through Follow up (Day 9) | Trough level concentration for defined dose regimen |
| Plasma PK profile (Tmax) | Baseline through Follow up (Day 9) | The time to peak drug concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Baseline through Follow up (Day 9) | Adverse events (AEs) and serious adverse events (SAEs) |
Countries
Netherlands
Outcome results
None listed