Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
Brief Summary: The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.


Options:
A: 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
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: 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
D: 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

Answer: C