Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponesimod i.v · 1 trial · 1 indication
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 ...
Ponesimod i.v is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to investigate the absolute bioavailability of a single oral dose of ponesimod in healthy male subjects. The drug is not approved and is still in clinical development.
Ponesimod i.v is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's properties in healthy subjects.
Ponesimod i.v is in Phase 1 of clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with a total enrollment of 17 healthy male subjects.
Ponesimod i.v has one completed clinical trial registered as NCT02068235. This Phase 1 study investigated the absolute bioavailability of a single oral dose of ponesimod in healthy male subjects. The trial was conducted in the United Kingdom and enrolled 17 participants.
Ponesimod i.v refers to the intravenous formulation of ponesimod, while the clinical trial NCT02068235 studied a single oral dose of ponesimod. The drug is being developed by Johnson & Johnson for potential therapeutic use, though it is currently only studied in healthy volunteers.