Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Brief Summary: This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.


Options:
A: Arm Label: Part A: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Arm Label: Part B: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): Part A: ELX/TEZ/IVA, Part B: ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part A: ELX/TEZ/IVA, Part B: ELX/TEZ/IVA
B: Arm Label: VX-659/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: VX-659/TEZ/IVA; Assigned to Arm(s): VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): VX-659/TEZ/IVA TC
C: 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
D: Arm Label: Part A: Pooled Placebo (Except Cohort A7); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part A: VX-445 (Except Cohort A7); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part A: VX-445 (Cohort A7); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part B: Pooled Placebo (Cohort B1 to B4); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part B: VX-445 (Cohort B1 to B4); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part C: Pooled Placebo (Cohort C1 to C3); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3); Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part D: VX-445/TEZ/IVA TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: VX-445/TEZ/IVA TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: VX-445/TEZ/IVA TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part E: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA | Arm Label: Part E: VX-445/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part F: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part F: VX-445/TEZ/VX-561 TC; Type: EXPERIMENTAL; Interventions: Drug: VX-445, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: TEZ/IVA, Part E: VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: VX-445; Assigned to Arm(s): Part A: VX-445 (Cohort A7), Part A: VX-445 (Except Cohort A7), Part B: VX-445 (Cohort B1 to B4), Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: VX-445/TEZ/IVA TC, Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: Matched Placebo; Assigned to Arm(s): Part A: Pooled Placebo (Except Cohort A7), Part B: Pooled Placebo (Cohort B1 to B4), Part C: Pooled Placebo (Cohort C1 to C3), Part D: Placebo, Part F: Placebo | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-445; Assigned to Arm(s): Part A: VX-445 (Cohort A7)

Answer: A