Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: VX-445/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-445/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: VX-445/TEZ/IVA; Assigned to Arm(s): VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: 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
C: 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
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: D