Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cladribine · 2 trials · 2 indications
Area under the plasma concentration-time curve from zero to tau at steady state (AUCt,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated using descriptive statistics.
Maximum observed plasma concentration in steady state (Cmax,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated using descriptive statistics.
Minimum observed plasma concentration in steady state (Cmin,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated from descriptive statistics.
Plasma concentration at end of dosing interval at steady state (Ctrough) of ethinyl estradiol and levonorgestrel were reported. Calculated from descriptive statistics.
Time to reach the maximum observed plasma concentration at steady state (Tmax,ss) of Ethinyl Estradiol and Levonorgestrel were reported. Calculated using descriptive statistics.
Average plasma concentration at steady state (Cav,ss) ) of Ethinyl Estradiol and Levonorgestrel were reported. Cav,ss =AUCt,ss/ tau, where, AUCt,ss was defined as the area under the plasma concentration-time curve in steady state during a complete dosing interval (tau) and Tau is the Complete dosing interval. Calculated using descriptive statistics.
The PTF within complete dosing interval at steady state, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav) multiplied by 100. Here, Cmin means the minimum plasma concentration, Cmax means the maximum plasma concentration and Cav means the average plasma concentration of drug and metabolite.
The maximum or peak plasma concentration observed after the administration of cladribine.
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
| Arm | Type | Description |
|---|---|---|
| Sequence 1: First Cladribine, Then Placebo | EXPERIMENTAL | Period 1: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine 10 to 20 milligram(mg) depending on body weight along with Microgynon® tablet once daily from Day 9-28. Period 2: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine matched Placebo along with Microgynon® from Day 9-14. From Day 15-28 participants received once daily Microgynon® along with 5-day once-daily Cladribine 10 to 20 mg depending on body weight. |
| Sequence 2: First Placebo, Then Cladribine | EXPERIMENTAL | Participants 5-day once daily Period 1: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine matched Placebo along with Microgynon® tablet once daily from Day 9-28. Period 2: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine 10 to 20 mg depending on body weight along with Microgynon® tablet once daily from Day 9-28. |
| Microgynon® | EXPERIMENTAL | Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle. |
| Cladribine followed by Cladribine + Pantoprazole | EXPERIMENTAL | Subjects will receive a single dose of cladribine10 milligram (mg) orally on Day 1. After a wash out period of 10-25 days, subjects will receive pantoprazole 40 mg orally for 2 consecutive days. On Day 2 of the pantoprazole administration, a single dose of cladribine 10 mg will be administered orally 3 hours after the second pantoprazole dose. |
| Cladribine + pantoprazole followed by Cladribine | EXPERIMENTAL | Subjects will receive pantoprazole 40 mg orally for 2 consecutive days. On Day 2 of the pantoprazole administration, a single dose of cladribine 10 mg will be administered orally 3 hours after the second pantoprazole dose. After a wash out period of 10-25 days, subjects will receive a single dose of cladribine 10 mg orally. |
| Name | Type | Description |
|---|---|---|
| Cladribine | DRUG | Participants received cladribine once-daily for 5 consecutive days in treatment period 1 and 2. |
| Placebo | DRUG | Participants received placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2. |
| Microgynon® | DRUG | Participants received Microgynon® tablet once daily for 21 days in treatment period 1 and 2. Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle in Run-in period. |
| Pantoprazole | DRUG | Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period. |
Inclusion Criteria: * Are pre-menopausal women with or without child-bearing potential with a negative serum pregnancy test, and women with child-bearing potential receiving adequate birth control * Participants with diagnosis of clinically stable and definite relapsing multiple sclerosis (RMS) * A...
Cladribine is a small molecule being developed by Merck KGaA for the treatment of Multiple Sclerosis, including Relapsing Multiple Sclerosis (RMS). It is currently in Phase 1 clinical development for these neurological conditions.
Cladribine is developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is being studied as a treatment for Multiple Sclerosis and Relapsing Multiple Sclerosis.
Cladribine is in Phase 1 clinical development. It is an investigational drug for Multiple Sclerosis and Relapsing Multiple Sclerosis, and it is not yet approved for these indications.
Cladribine has been studied in two completed Phase 1 trials. One trial, NCT00938366, examined drug-drug interactions with pantoprazole in Multiple Sclerosis subjects. Another trial, NCT03745144, studied the effects of Cladribine tablets on the pharmacokinetics of Microgynon in Relapsing Multiple Sclerosis patients.
Cladribine is the active ingredient in the product Mavenclad, which is used for treating relapsing forms of multiple sclerosis. The clinical trials listed for Cladribine tablets are part of its development for Multiple Sclerosis and Relapsing Multiple Sclerosis.