Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.


Options:
A: Arm Label: Cohort 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2 and 3: Placebo (HO and HE); Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 4: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Intervention Type: DRUG; Name: Lumacaftor; Assigned to Arm(s): Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h, Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h, Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE), Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO), Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h, Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h, Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE), Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO), Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h | Intervention Type: DRUG; Name: Lumacaftor Placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2 and 3: Placebo (HO and HE), Cohort 4: Placebo | Intervention Type: DRUG; Name: Ivacaftor Placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2 and 3: Placebo (HO and HE), Cohort 4: Placebo
B: Arm Label: N91115 + Rifampin; Type: EXPERIMENTAL; Interventions: Drug: N91115, Drug: Rifampin | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): N91115 + Rifampin | Intervention Type: DRUG; Name: Rifampin; Assigned to Arm(s): N91115 + Rifampin
C: Arm Label: Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 5 Part A: Observational Cohort; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 7 Part B: Placebo - 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): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h, Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h, Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h
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: A