Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double Blind, Dose Escalation, Fusion, First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Subjects
Brief Summary: This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled, double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2) iii. Single doses in chronically infected HCV positive subjects (Part 3).


Options:
A: Arm Label: TMC435 100 mg 12 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 100 mg 24 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 100 mg 48 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 12 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 24 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 48 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: Placebo 48 Wks + PR48; Type: PLACEBO_COMPARATOR; Interventions: Drug: TMC435, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48 | Intervention Type: DRUG; Name: Peg-IFN-alfa-2a (P); Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48 | Intervention Type: DRUG; Name: Ribavirin (R); Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48
B: Arm Label: TMC435; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Drug: Ribavirin (RBV) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Drug: Ribavirin (RBV) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): TMC435 | Intervention Type: DRUG; Name: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b); Assigned to Arm(s): Placebo, TMC435 | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): Placebo, TMC435
C: Arm Label: Part 1: Single Dose Escalation in Healthy Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2336805 10mg, Drug: GSK2336805 30mg, Drug: GSK2236805 100mg, Drug: GSK2236805 200mg | Arm Label: Part 2: Repeat Dose Escalation in Healthy Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2236805 10mg, Drug: GSK2236805 dose to be determined up to 100mg | Arm Label: Part 3: Single Dose Escalation in HCV Infected Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2236805 5mg, Drug: GSK2236805 30mg, Drug: GSK2236805 100mg | Intervention Type: DRUG; Name: GSK2336805 10mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2336805 30mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 100mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 200mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 10mg; Assigned to Arm(s): Part 2: Repeat Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 dose to be determined up to 100mg; Assigned to Arm(s): Part 2: Repeat Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 5mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects | Intervention Type: DRUG; Name: GSK2236805 30mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects | Intervention Type: DRUG; Name: GSK2236805 100mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects
D: Arm Label: 001 T(q8h) / PR; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: Pegylated interferon alfa-2a, Drug: Telaprevir | Arm Label: 002 T(b.i.d.) / PR; Type: EXPERIMENTAL; Interventions: Drug: Ribavirin, Drug: Telaprevir, Drug: Pegylated interferon alfa-2a | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): 001 T(q8h) / PR, 002 T(b.i.d.) / PR | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): 002 T(b.i.d.) / PR | Intervention Type: DRUG; Name: Pegylated interferon alfa-2a; Assigned to Arm(s): 001 T(q8h) / PR, 002 T(b.i.d.) / PR | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): 001 T(q8h) / PR

Answer: C