Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-64146212
AL-335 · 3 trials · 2 indications
An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.
The Cmax is the maximum observed concentration of analyte (AL-335).
The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration.
The AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Chronic Hepatitis C Without Cirrhosis) | EXPERIMENTAL | Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1. |
| Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) | EXPERIMENTAL | Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC). |
| Group A | EXPERIMENTAL | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks. |
| Group B | EXPERIMENTAL | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks. |
| AL-335 (Cohort 1) | EXPERIMENTAL | Participants with mild impaired renal function will receive a single oral dose of AL-335 800 milligram (mg) (given as 2\*400-mg tablets). |
| AL-335 (Cohort 2) | EXPERIMENTAL | Participants with moderate impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets). |
| AL-335 (Cohort 3) | EXPERIMENTAL | Participants with severe impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets). |
| AL-335 (Cohort 4) | EXPERIMENTAL | Participants with normal renal function will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets). |
| Name | Type | Description |
|---|---|---|
| AL-335 | DRUG | Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
| Odalasvir (ODV) | DRUG | Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
| Simeprevir (SMV) | DRUG | Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2. |
| Odalasvir | DRUG | Odalasvir 25 mg tablet will be administered once daily. |
| Simeprevir | DRUG | Simeprevir 75 mg capsule will be administered once daily. |
Inclusion Criteria: * 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 * D...
AL-335 is an investigational small molecule antiviral developed by Johnson & Johnson for the treatment of chronic hepatitis C virus infection. It has been studied both as part of combination regimens with other direct acting antivirals and in participants with renal insufficiency. It remains in clinical development and is not an approved medicine.
AL-335 was studied for the treatment of chronic hepatitis C, including genotype 1 and genotype 2 infections, in people with or without compensated cirrhosis who had not previously received direct acting antiviral treatment. It was also evaluated in a study of renal insufficiency. All reported trials are completed.
AL-335 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the clinical program evaluating the drug in chronic hepatitis C and in renal insufficiency.
AL-335 is in Phase 2 development. Two Phase 2 trials and one Phase 1 trial have been completed, and no trials are currently listed as active. The drug is investigational and has not been approved for any indication.
Three completed trials studied AL-335. NCT02765490 was a Phase 2 study of AL-335 combined with odalasvir and simeprevir in 365 participants with chronic hepatitis C across Belgium, Canada, Germany, Poland, Singapore and Spain. NCT02993250 was a Phase 2 study in 33 Japanese participants, and NCT02894905 was a Phase 1 renal impairment pharmacokinetics study in 24 participants.