A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic
      (what the body does to a medication) of GSK2336805 alone and with the co-administration of
      TMC435 in healthy Japanese participants.
    

Detailed description: 
      This study will consists of 2 parts (Part 1 and 2) which will be sequentially conducted in 2
      separate panels of 24 healthy adult Japanese participants each, at a single center. Part 1 is
      a double-blind (neither physician nor participant knows the treatment that the participant
      receives), placebo-controlled (placebo is compared with the study medication to test whether
      the study medication has a real effect in clinical study), randomized (study medication is
      assigned by chance), single ascending dose study to investigate the safety, tolerability, and
      pharmacokinetics of GSK2336805 in participants. It will consist of a screening phase, a
      treatment phase, and a follow-up phase. The maximum study duration for each participant will
      be approximately 5 weeks (including screening and follow-up phase). 24 participants will be
      equally divided in 3 cohorts with 8 participants in each cohort. In each cohort, participants
      will be randomly assigned to receive either a single oral dose of GSK2336805 (6 participants)
      or placebo (2 participants). Part 2 is an open-label (all people know the identity of the
      intervention), randomized, 4-way crossover study (method used to switch patients from one
      treatment arm to another in a clinical study) to investigate the potential pharmacokinetic
      drug-drug interactions between TMC435 and GSK2336805 at steady-state, and to evaluate the
      short-term safety and tolerability when TMC435 and GSK2336805 are co-administered in
      participants. It will consist of a screening phase, a treatment phase (4 treatment sessions
      [Treatment A, B, C, and D]), and a follow-up phase. The maximum study duration for each
      participant will be approximately 12 weeks (including screening and follow-up phase). During
      4 treatment sessions, each of the 24 participants will receive Treatment A, B, C and D
      consecutively in different sequences with a washout period of at least 7 days between
      consecutive treatment sessions in each individual participant. Safety will be evaluated by
      assessing adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical
      examination, alcohol breath tests, and specific toxicities.
    

Intervention name(s): GSK2336805 30 mg; GSK2336805 60 mg; GSK2336805 120 mg; TMC435 150 mg (Treatment A); GSK2336805 60 mg (Treatment B and part of Treatment C and D); TMC435 100 mg (part of Treatment C); TMC435 150 mg (part of treatment D)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 1 tablet of 30 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.; A single dose of 2 tablets of 30 mg ie, 60 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.; A single dose of 4 tablets of 30 mg ie, 120 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.; 1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.; 2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.; 1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.; 1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy; TMC435; GSK2336805; Pharmacokinetic; Safety; Tolerability