Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Brief Summary: This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).


Options:
A: Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/IVA) | Arm Label: Part 1: VX-659/TEZ/IVA TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 1: VX-659/TEZ/IVA TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: VX-659/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-659/TEZ/VX-561) | Arm Label: Part 3: VX-659/TEZ/VX-561 TC; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: VX-659; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: VX-659/TEZ/IVA TC, Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part 1: VX-659/TEZ/IVA TC - High Dose, Part 1: VX-659/TEZ/IVA TC - Low Dose, Part 1: VX-659/TEZ/IVA TC - Medium Dose, Part 2: TEZ/IVA, Part 2: VX-659/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/IVA); Assigned to Arm(s): Part 1: Placebo | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part 3: VX-659/TEZ/VX-561 TC | Intervention Type: DRUG; Name: Placebo (matched to VX-659/TEZ/VX-561); Assigned to Arm(s): Part 3: Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: LUM 600 mg qd/IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): LUM 400 mg q12h/ IVA 250 mg q12h, LUM 600 mg qd/IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): LUM 600 mg qd/IVA 250 mg q12h
C: Arm Label: Part A: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM, Drug: IVA | Arm Label: Part B: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM, Drug: IVA | Intervention Type: DRUG; Name: LUM; Assigned to Arm(s): Part A: LUM/IVA, Part B: LUM/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part A: LUM/IVA, Part B: LUM/IVA
D: Arm Label: Baseline; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Miglustat; Type: ACTIVE_COMPARATOR; Interventions: Drug: Miglustat | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Miglustat; Assigned to Arm(s): Miglustat | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C