Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL-335 · 4 trials · 3 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.
The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC\[tau\]) divided by the dosing interval (tau).
The Cmax is the maximum observed analyte concentration.
The Cmin is the minimum observed analyte concentration during dosing interval.
The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The AUC24 is the area under the analyte concentration-time curve from time 0 to 24 hours.
Fluctuation Index is defined as percentage of fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100\*(\[Cmax-Cmin\]/Cavg).
The (AUC \[0-last\]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
The AUC (0-infinity) 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.
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Elimination half-life (t\[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
| 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). |
| AL-335+Simeprevir (SMV)+Odalasvir (ODV) | EXPERIMENTAL | Participants will receive AL-335 800 milligram (mg) once daily from day 1-3; SMV 75 mg once daily from Day 4-13; loading dose of ODV 150 mg on Day 14, followed by ODV 50 mg once daily from Day 15 to 23; ODV 50 mg once daily + AL-335 800 mg once daily from day 24-26; ODV 50 mg once daily + SMV 75 mg once daily from Day 27-33 and ODV 50 mg once daily + SMV 75 mg once daily + AL-335 800 mg once daily from Day 34 to 36. |
| 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 being studied for the treatment of chronic hepatitis C infection. It has also been evaluated in healthy volunteers and in people with renal insufficiency to assess its safety and pharmacokinetics. The drug is not approved and remains in clinical development.
AL-335 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule and has not been approved by regulatory authorities.
AL-335 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and is not FDA approved. The completed trials include a Phase 2 study in chronic hepatitis C and Phase 1 studies in healthy participants and those with renal impairment.
AL-335 has been studied in several completed trials. NCT02765490 was a Phase 2 trial in chronic hepatitis C with 365 participants. NCT02824315 was a Phase 1 healthy volunteer study in Japan. NCT02894905 evaluated renal impairment, and NCT02993250 was a Phase 2 trial in Japanese patients with hepatitis C.
No, AL-335 is a distinct investigational drug. It has been studied in combination with odalasvir and simeprevir, which are other direct-acting antiviral agents. The combination therapy was evaluated in clinical trials for chronic hepatitis C, but AL-335 itself is a separate compound.