Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.


Options:
A: Arm Label: GLPG2737; Type: EXPERIMENTAL; Interventions: Drug: GLPG2737 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: GLPG2737; Assigned to Arm(s): GLPG2737 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: N6022; Type: EXPERIMENTAL; Interventions: Drug: N6022 | Arm Label: Normal saline; Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal saline | Intervention Type: DRUG; Name: N6022; Assigned to Arm(s): N6022 | Intervention Type: DRUG; Name: Normal saline; Assigned to Arm(s): Normal saline
C: Arm Label: Cohort 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2 and 3: Placebo (HO and HE); Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 4: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Intervention Type: DRUG; Name: Lumacaftor; Assigned to Arm(s): Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h, Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h, Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE), Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO), Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h, Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h, Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE), Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO), Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h | Intervention Type: DRUG; Name: Lumacaftor Placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2 and 3: Placebo (HO and HE), Cohort 4: Placebo | Intervention Type: DRUG; Name: Ivacaftor Placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2 and 3: Placebo (HO and HE), Cohort 4: Placebo
D: Arm Label: Ivacaftor; Type: ACTIVE_COMPARATOR; Interventions: Drug: IVA, Drug: Placebo | Arm Label: VX-561: 25 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Arm Label: VX-561: 50 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Arm Label: VX-561: 150 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Arm Label: VX-561: 250 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-561, Drug: Placebo | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): VX-561: 150 mg, VX-561: 25 mg, VX-561: 250 mg, VX-561: 50 mg | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Ivacaftor | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): VX-561: 150 mg, VX-561: 25 mg, VX-561: 250 mg, VX-561: 50 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ivacaftor

Answer: C