Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).


Options:
A: Arm Label: Fingolimod (FTY720) 1.25 mg/day; Type: EXPERIMENTAL; Interventions: Drug: FTY720 | Arm Label: Placebo/Fingolimod (FTY720); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Fingolimod (FTY720) 5.0 mg/day; Type: EXPERIMENTAL; Interventions: Drug: FTY720 | Intervention Type: DRUG; Name: FTY720; Assigned to Arm(s): Fingolimod (FTY720) 1.25 mg/day, Fingolimod (FTY720) 5.0 mg/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo/Fingolimod (FTY720)
B: Arm Label: FTY720 0.5 mg; Type: EXPERIMENTAL; Interventions: Drug: FTY720 | Arm Label: FTY720 1.25 mg; Type: EXPERIMENTAL; Interventions: Drug: FTY720 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: FTY720; Assigned to Arm(s): FTY720 0.5 mg, FTY720 1.25 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: BG00012 240 mg Twice Daily (BID); Type: EXPERIMENTAL; Interventions: Drug: BG00012, Drug: Placebo | Arm Label: BG00012 240 mg 3 Times Daily (TID); Type: EXPERIMENTAL; Interventions: Drug: BG00012 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD); Type: ACTIVE_COMPARATOR; Interventions: Drug: Glatiramer Acetate | Intervention Type: DRUG; Name: BG00012; Assigned to Arm(s): BG00012 240 mg 3 Times Daily (TID), BG00012 240 mg Twice Daily (BID) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BG00012 240 mg Twice Daily (BID), Placebo | Intervention Type: DRUG; Name: Glatiramer Acetate; Assigned to Arm(s): Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
D: Arm Label: DAC HYP; Type: EXPERIMENTAL; Interventions: Drug: Midazolam, Other: Caffeine, Drug: S-warfarin, Other: Vitamin K, Drug: Omeprazole, Drug: Dextromethorphan, Biological: BIIB019 (Daclizumab) | Intervention Type: DRUG; Name: Midazolam; Assigned to Arm(s): DAC HYP | Intervention Type: OTHER; Name: Caffeine; Assigned to Arm(s): DAC HYP | Intervention Type: DRUG; Name: S-warfarin; Assigned to Arm(s): DAC HYP | Intervention Type: OTHER; Name: Vitamin K; Assigned to Arm(s): DAC HYP | Intervention Type: DRUG; Name: Omeprazole; Assigned to Arm(s): DAC HYP | Intervention Type: DRUG; Name: Dextromethorphan; Assigned to Arm(s): DAC HYP | Intervention Type: BIOLOGICAL; Name: BIIB019 (Daclizumab); Assigned to Arm(s): DAC HYP

Answer: D