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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 (Formulation 1, 2, and 3) | Experimental | Participants randomized to Treatment Sequence 1 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 2, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
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| Treatment Sequence 2 (Formulation 2, 3, and 1) | Experimental | Participants randomized to Treatment Sequence 2 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 3, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
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| Treatment Sequence 3 (Formulation 3, 1, and 2) | Experimental | Participants randomized to Treatment Sequence 3 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 1, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
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| Treatment Sequence 4 (Formulation 2, 1, and 3) | Experimental | Participants randomized to Treatment Sequence 4 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 3, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
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| Treatment Sequence 5 (Formulation 2, 1, and 3) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QRL-101 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK profile (AUCinf) | The area under the curve to infinity | Baseline through Follow up (Day 9) |
| Plasma PK profile (AUClast) | The area under the curve to the last measurable time point | Baseline through Follow up (Day 9) |
| Plasma PK profile (Cmax) | Maximum concentration observed | Baseline through Follow up (Day 9) |
| Plasma PK profile (Ctrough) | Trough level concentration for defined dose regimen | Baseline through Follow up (Day 9) |
| Plasma PK profile (Tmax) | The time to peak drug concentration | Baseline through Follow up (Day 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Adverse events (AEs) and serious adverse events (SAEs) | Baseline through Follow up (Day 9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salah Hadi, MD | ICON plc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON plc. Van Swietenlaan 6 | Groningen | 9728 NZ | Netherlands |
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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.
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A participant and investigator-blinded, randomized, open-label, single-dose, cross-over design will be used to minimize bias in this study.
| Experimental |
Participants randomized to Treatment Sequence 5 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 1, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
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| Treatment Sequence 6 (Formulation 3, 2, and 1) | Experimental | Participants randomized to Treatment Sequence 6 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 2, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
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