Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
Brief Summary: This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic exposure level in preparation for Phase 2 studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.


Options:
A: Arm Label: Part A: VX-659 or Matching Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: VX-659 Matching Placebo | Arm Label: Part B: VX-659 or Matching Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: VX-659 Matching Placebo | Arm Label: Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: Tezacaftor, Drug: Ivacaftor, Drug: Triple Combination (TC) Matching Placebos | Arm Label: Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: Tezacaftor, Drug: Ivacaftor, Drug: Triple Combination (TC) Matching Placebos | Intervention Type: DRUG; Name: VX-659; Assigned to Arm(s): Part A: VX-659 or Matching Placebo, Part B: VX-659 or Matching Placebo, Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: Tezacaftor; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: VX-659 Matching Placebo; Assigned to Arm(s): Part A: VX-659 or Matching Placebo, Part B: VX-659 or Matching Placebo | Intervention Type: DRUG; Name: Triple Combination (TC) Matching Placebos; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo
B: Arm Label: Ataluren; Type: EXPERIMENTAL; Interventions: Drug: Ataluren | Intervention Type: DRUG; Name: Ataluren; Assigned to Arm(s): Ataluren
C: Arm Label: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): ELX/TEZ/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: D