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A Phase 2a, Multicenter, Open-label Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Subjects With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis who are Direct acting Antiviral Treatment-naive

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis who are Direct Acting Antiviral Treatment-naive

Janssen Pharmaceutical K.K., Japan

Tel: 0120-183-275, Fax: 0120-275-831 Office Hours 9:00 - 17:40 (closed on Saturdays, Sundays, Official holidays and company holidays)

Interventional

Open Label Non-randomized

2

- Chronic hepatitis C virus (HCV) infection
- All participants must have HCV genotype 1 or 2 infection, determined at screening
- HCV ribonucleic acid (RNA) plasma levels greater than or equal to (>=)10,000 international units per Milliliter (IU/mL), determined at screening
- Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed
- Participants without cirrhosis or with compensated cirrhosis

- Infection with HCV genotype - 3, 4, 5, or 6
- Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive)
- Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free
- Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator
- Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy

Both

Hepatitis C, Chronic

investigational material(s)
Generic name etc : AL-335
INN of investigational material :
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

control material(s)
Generic name etc : Odalasvir (ODV)
INN of investigational material :
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Generic name etc : Simeprevir (SMV)
INN of investigational material :
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability

- Plasma Concentration of AL-335 up to Week 12 Follow-up Visit

- Plasma Concentration of Odalasvir (ODV) up to Week 12 Follow-up Visit

- Plasma Concentration of Simeprevir (SMV) up to Week 12 Follow-up Visit

- Percentage of Participants with Sustained Virologic Response 4 Weeks(SVR4) After Actual End-of-treatment at 4 weeks after End of Treatment (EOT)

- Percentage of Participants with Sustained Virologic Response 12 Weeks(SVR12) After Actual End-of-treatment at 12 weeks after EOT

- Percentage of Participants with Sustained Virologic Response 24 Weeks(SVR24) After Actual End-of-treatment at 24 weeks after EOT

- Percentage of Participants With Viral Relapse up to 24 weeks after EOT

- Percentage of Participants With Ontreatment Failure up to 24 weeks after EOT

- Percentage of Participants With Ontreatment Virologic Response up to 24 weeks after EOT

- Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ up to 24 weeks after EOT