A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of a single supratherapeutic dose of
      AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus
      placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using
      intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT/QTc and
      PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response
      (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV
      on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy
      participants.
    


Intervention name(s): ODV Placebo (Matching 25 mg ODV); ODV Placebo (Matching 200 mg ODV); ODV Placebo (Matching 125 mg ODV); ODV Placebo (Matching 100 mg ODV); SMV Placebo (Matching 150 mg SMV); AL-335 Placebo (matching 1200 mg AL-335); Moxifloxacin Placebo (matching 400 mg moxifloxacin); ODV 25 mg; ODV 200 mg; ODV 125 mg; ODV 100 mg; SMV 150 mg; AL-335 1200 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive ODV placebo (matching 25 [mg] ODV [1*25 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1.; Participants will receive ODV placebo (matching 200 mg ODV [4*50 mg tablets]) on Days 1 and 2 in Treatment E.; Participants will receive ODV placebo (matching 125 mg ODV [2*50 mg tablets + 1*25 mg tablets]) orally once daily on Days 3 to 7 in Treatment E.; Participants will receive ODV placebo (matching 100 mg ODV [2*50 mg tablets] orally once daily on Days 8 to 14 in Treatment E.; Participants will receive SMV Placebo (matching 150 mg SMV [2*75 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C.; Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 [3*400 mg tablets]) administered orally on Day 15 in Treatment A and B.; Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1*400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C.; Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C.; Participants will receive ODV 200 mg (4*50 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F.; Participants will receive ODV 125 mg (2*50 mg tablets + 1*25 mg tablets) once daily administered on Days 3 to 7 in Treatment F.; Participants will receive ODV 100 mg (2*50 mg tablets) orally once daily administered on Days 8 to 14 in Treatment F.; Participants will receive SMV 150 mg (2*75 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C.; Participants will receive a single oral dose of AL-335 1200 mg (3*400 mg tablets) administered on Day 15 in Treatment C.
Intervention MeSH terms: Moxifloxacin; Adafosbuvir; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other