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This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCQ908 (mild renal impairment plus healthy volunteers) | Experimental | Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with mild renal impairment and will receive a single 40 mg dose of LCQ908. |
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| LCQ908 (moderate renal impairment plus healthy volunteers) | Experimental | Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with moderate renal impairment and will receive a single 40 mg dose of LCQ908. |
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| LCQ908 (severe renal impairment plus healthy volunteers) | Experimental | Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with severe renal impairment and will receive a single 40 mg dose of LCQ908. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCQ908 | Drug | Participants will receive a single oral dose of LCQ908 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing | |
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing | |
| Maximum plasma concentration (Cmax) of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs), serious adverse events (SAEs) and death | AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital abnormalities or birth defects, or are other conditions which in the judgment of investigators represent significant hazards. |
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Inclusion Criteria:
Individuals with renal impairment only
Healthy subjects only • Estimated CLcr by the Cockroft-Gault equation >80mL/min
Exclusion Criteria:
All Individuals
Individuals with renal impairment
Healthy subjects
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Orlando | Florida | 32809 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLCQ908B2102 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000594809 | pradigastat |
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| Day 29 |
| The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
| Time to maximum plasma concentration of LCQ908 | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
| The time required for the concentration of the drug to reach half of its original value | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
| Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration | Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing |
| LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908 | 10 and 24 hours |
| LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908 | 10 and 24 hours |
| LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration | 10 and 24 hours |
| Knoxville |
| Tennessee |
| 37920 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |