Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.


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: N91115 + Rifampin; Type: EXPERIMENTAL; Interventions: Drug: N91115, Drug: Rifampin | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): N91115 + Rifampin | Intervention Type: DRUG; Name: Rifampin; Assigned to Arm(s): N91115 + Rifampin
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: VX-661/Ivacaftor combination; Type: EXPERIMENTAL; Interventions: Drug: VX-661/Ivacaftor, Drug: Ivacaftor, Drug: Placebo matched to Ivacaftor | Arm Label: Ivacaftor monotherapy; Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor, Drug: Placebo matched to VX-661/ ivacaftor | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo matched to VX-661/ ivacaftor, Drug: Placebo matched to Ivacaftor | Intervention Type: DRUG; Name: VX-661/Ivacaftor; Assigned to Arm(s): VX-661/Ivacaftor combination | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Ivacaftor monotherapy, VX-661/Ivacaftor combination | Intervention Type: DRUG; Name: Placebo matched to VX-661/ ivacaftor; Assigned to Arm(s): Ivacaftor monotherapy, Placebo | Intervention Type: DRUG; Name: Placebo matched to Ivacaftor; Assigned to Arm(s): Placebo, VX-661/Ivacaftor combination

Answer: A