Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis
Brief Summary: This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).


Options:
A: Arm Label: VX-661/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-661 plus ivacaftor combination, Drug: Ivacaftor | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-661 plus ivacaftor combination), Drug: Placebo (matched to ivacaftor) | Intervention Type: DRUG; Name: VX-661 plus ivacaftor combination; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: Placebo (matched to VX-661 plus ivacaftor combination); Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Placebo (matched to ivacaftor); Assigned to Arm(s): Placebo
B: Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/IVA) | Arm Label: Part 1: VX-659/TEZ/IVA TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: VX-659/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/VX-561) | Arm Label: Part 3: VX-659/TEZ/VX-561 TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: VX-659; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: VX-659/TEZ/IVA TC, Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/IVA); Assigned to Arm(s): Part 1: Placebo | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/VX-561); Assigned to Arm(s): Part 3: Placebo
C: Arm Label: 10 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 50 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 50 mg (single dose); Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 250 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 250 mg (Fed); Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 500 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Placebo-Day 1 only; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo-Day 1 only | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): 10 mg, 250 mg, 50 mg, 500 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): 250 mg (Fed), 50 mg (single dose) | Intervention Type: DRUG; Name: Placebo-Day 1 only; Assigned to Arm(s): Placebo-Day 1 only
D: Arm Label: Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 5 Part A: Observational Cohort; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h, Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h, Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h

Answer: B