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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02068235 | Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects | PHASE1 | COMPLETED | 17 | — | — | Aug 1, 2014 | Nov 1, 2014 | May 21, 2015 | 1 | United Kingdom |
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. AUC(0-144) will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification.
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. AUC(0-infinity) will be calculated by combining AUC(0-144) and AUC(extra). AUC(extra) represents an extrapolated value obtained by Ct/λz, where Ct is the last plasma concentration measured above the limit of quantification and λz represents the terminal elimination rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal elimination phase.
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. Cmax will be calculated on the basis of the blood sampling time points.
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. t1/2 will be calculated on the basis of the blood sampling time points.
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. tmax will be calculated on the basis of the blood sampling time points.
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. CL Total body clearance will be calculated as follows: CL = Dose / AUC(0-infinity).
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. Vss will be estimated by CL \[(AUMC/AUC) - (infusion time/2)\], where AUMC is the area under the first moment curve.
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. F will be calculated using the geometric means (as derived by the mixed effect model) of AUC(0-infinity).
| Arm | Type | Description |
|---|---|---|
| Pilot Phase | EXPERIMENTAL | Subjects will receive a single intravenous (i.v.) dose of 5 mg ponesimod dissolved in 50 mL sterile 0.9% sodium chloride (NaCl) solution as a 3-hour infusion in the fasted state in the morning (infusion rate: 0.028 mg/min). |
| Treatment A/Treatment B | EXPERIMENTAL | Subjects will receive Treatment A followed by Treatment B. Treatment A: a single i.v. dose of ponesimod administered in the fasted state in the morning. Treatment B: a single oral dose of ponesimod (10 mg) administered as 1 tablet in the fasted state in the morning. There will be a washout period between doses of 12-15 days. |
| Treatment B/Treatment A | EXPERIMENTAL | Subjects will receive Treatment B followed by Treatment A. Treatment A: a single i.v. dose of ponesimod administered in the fasted state in the morning. Treatment B: a single oral dose of ponesimod (10 mg) administered as 1 tablet in the fasted state in the morning. There will be a washout period between doses of 12-15 days. |
| Name | Type | Description |
|---|---|---|
| Ponesimod 5mg i.v. | DRUG | - |
| Ponesimod i.v. | DRUG | Dose and infusion rate will be adjusted according to the results of the pilot phase |
| Ponesimod 10 mg tablet | DRUG | - |
Inclusion Criteria: * Signed informed consent in the local language prior to any study-mandated procedure. * Body mass index ≥ 18 and ≤ 28 kg/m\^2 at screening. * No clinically significant findings on the physical examination at screening. * Systolic blood pressure (SBP) 100-145 mmHg and diastolic ...