Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of VX-809 to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of VX-809 in Cystic Fibrosis Subjects Homozygous for the ∆F508-CFTR Gene Mutation
Brief Summary: The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.


Options:
A: Arm Label: Group 1-6d Combined: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo matched to VX-661, Drug: Placebo matched to ivacaftor | Arm Label: Group 1: VX-661 10 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661 | Arm Label: Group 2a: VX-661 30 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Placebo matched to ivacaftor | Arm Label: Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 3a: VX-661 100 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Placebo matched to ivacaftor | Arm Label: Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 5a: VX-661 150 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661 | Arm Label: Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Arm Label: Group 7: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ivacaftor, Drug: Placebo matched to VX-661 | Arm Label: Group 7: VX-661 100 mg qd; Type: EXPERIMENTAL; Interventions: Drug: VX-661, Drug: Ivacaftor | Intervention Type: DRUG; Name: VX-661; Assigned to Arm(s): Group 1: VX-661 10 mg qd, Group 2a: VX-661 30 mg qd, Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h, Group 3a: VX-661 100 mg qd, Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h, Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h, Group 5a: VX-661 150 mg qd, Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h, Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h, Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h, Group 7: VX-661 100 mg qd | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Group 2b: VX-661 10 mg qd/Ivacaftor 150 mg q12h, Group 3b: VX-661 30 mg qd/Ivacaftor 150 mg q12h, Group 4: VX-661 100 mg qd/Ivacaftor 150 mg q12h, Group 5b: VX-661 150 mg qd/Ivacaftor 150 mg q12h, Group 6a: VX-661 100 mg qd/Ivacaftor 50 mg q12h, Group 6d: VX-661 50 mg q12h/Ivacaftor 150 mg q12h, Group 7: Placebo, Group 7: VX-661 100 mg qd | Intervention Type: DRUG; Name: Placebo matched to VX-661; Assigned to Arm(s): Group 1-6d Combined: Placebo, Group 7: Placebo | Intervention Type: DRUG; Name: Placebo matched to ivacaftor; Assigned to Arm(s): Group 1-6d Combined: Placebo, Group 2a: VX-661 30 mg qd, Group 3a: VX-661 100 mg qd
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: VX-809, 25 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Arm Label: VX-809, 50 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Arm Label: VX-809, 100 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Arm Label: VX-809, 200 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Intervention Type: DRUG; Name: VX-809; Assigned to Arm(s): VX-809, 100 mg, VX-809, 200 mg, VX-809, 25 mg, VX-809, 50 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-809, Drug: VX-770 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: VX-809; Assigned to Arm(s): LUM/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: VX-770; Assigned to Arm(s): LUM/IVA
D: Arm Label: Group 1 - 50 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Group 2 - 100 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Group 3 - 200 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Group 4 - Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: N91115 | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): Group 1 - 50 mg, Group 2 - 100 mg, Group 3 - 200 mg, Group 4 - Placebo

Answer: B