Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Brief Summary: This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).


Options:
A: 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: 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 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: 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)
C: Arm Label: Placebo; Type: OTHER; Interventions: Drug: Placebo | Arm Label: TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: TEZ/IVA, Drug: IVA, Drug: Placebo | Arm Label: Ivacaftor; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: Placebo | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Ivacaftor, TEZ/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ivacaftor, Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo, 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: B