Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02959138 | Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function | PHASE1 | COMPLETED | 36 | — | — | Nov 21, 2016 | Oct 5, 2018 | Oct 25, 2019 | 6 | United States, Germany +1 |
AUClast is defined as the concentration of drug from time zero to the last observable concentration. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min
AUCinf is defined as the concentration of drug extrapolated to infinite time. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min
Cmax is defined as the maximum concentration of drug. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min
| Arm | Type | Description |
|---|---|---|
| Moderate Renal Impairment (Cohort 1) | EXPERIMENTAL | Participants with moderate renal impairment and matched healthy controls will receive a single dose of lanraplenib |
| Severe Renal Impairment (Adaptive Cohort 2) | EXPERIMENTAL | Participants with severe renal impairment and matched healthy controls will receive a single dose of lanraplenib |
| Mild Renal Impairment (Adaptive Cohort 3) | EXPERIMENTAL | Participants with mild renal impairment and matched healthy controls will receive a single dose of lanraplenib |
| Name | Type | Description |
|---|---|---|
| Lanraplenib. | DRUG | 20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1 |
Key Inclusion Criteria: All Individuals * Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures * Have a calculated body mass index (BMI) of ≥ 18 kg/m\^2 and ≤ 36 kg/m\^2 at screening * Females of childbearing ...