Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Brief Summary: A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: VX-661 Plus Ivacaftor Combination Placebo, Drug: Ivacaftor placebo | Arm Label: VX-661/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-661 Plus Ivacaftor Combination, Drug: Ivacaftor | Intervention Type: DRUG; Name: VX-661 Plus Ivacaftor Combination; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: VX-661 Plus Ivacaftor Combination Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Ivacaftor placebo; Assigned to Arm(s): Placebo
B: Arm Label: 10 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 50 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 50 mg (single dose); Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 250 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 250 mg (Fed); Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: 500 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Placebo-Day 1 only; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo-Day 1 only | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): 10 mg, 250 mg, 50 mg, 500 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): 250 mg (Fed), 50 mg (single dose) | Intervention Type: DRUG; Name: Placebo-Day 1 only; Assigned to Arm(s): Placebo-Day 1 only
C: 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
D: 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

Answer: B