Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Odalasvir · 4 trials · 2 indications
Cmax is the maximum observed analyte concentration.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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(0-last) and C(last)/lambda(z); wherein AUC(0-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 Cmax is the maximum observed plasma analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
The AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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(0-last) and C(last)/lambda(z); wherein AUC(0-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.
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
The Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\].
The CL/F is defined as Dose/AUC (0-infinity).
A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in QTc over time.
The Cmax is the maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The (AUC \[0-last\]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
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).
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.
The Cmax is the maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed concentration.
The (AUC \[0-last\]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
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).
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.
| Arm | Type | Description |
|---|---|---|
| Dabigatran etexilate mesylate+Odalasvir+Simeprevir | EXPERIMENTAL | All participants will receive study medications in a fixed sequential order as: a single dose of dabigatran etexilate mesylate 75 milligram (mg) on Days 1, 17 and 26; Odalasvir (ODV) 25 mg once daily from Day 4 to 28; Simeprevir (SMV) 75 mg once daily from Day 20 to 28. The study drugs will be taken orally. |
| Cohort 1 (Severe Renal Impairment): Odalasvir | EXPERIMENTAL | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
| Cohort 2 (Normal Renal Function): Odalasvir | EXPERIMENTAL | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
| Treatment A | EXPERIMENTAL | Participants will receive odalasvir 100 milligram (mg) or odalasvir matching placebo once on Day 1. |
| Treatment B | EXPERIMENTAL | Participants will receive odalasvir 500 mg or odalasvir matching placebo once on Day 1. |
| Treatment C | EXPERIMENTAL | Participants will receive odalasvir (dose to be determined based on pharmacokinetic data from treatment A and B but no more than 1000 mg) or odalasvir matching placebo once on Day 1. |
| Panel 1: Treatment A | EXPERIMENTAL | Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1. |
| Panel 1: Treatment B | EXPERIMENTAL | Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1. |
| Panel 1: Treatment C | EXPERIMENTAL | Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1. |
| Panel 2: Treatment D | EXPERIMENTAL | Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1. Each treatment period will be separated by a washout period of 7 days. |
| Panel 2: Treatment E | EXPERIMENTAL | Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days. |
| Panel 2: Treatment F | EXPERIMENTAL | Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3. Each treatment period will be separated by a washout period of 7 days. |
| Name | Type | Description |
|---|---|---|
| Dabigatran etexilate mesylate | DRUG | Participants will receive dabigatran etexilate mesylate 75 mg, orally. |
| Odalasvir (ODV) | DRUG | Participants will receive ODV 25 mg, orally. |
| Simeprevir (SMV) | DRUG | Participants will receive SMV 75 mg, orally. |
| Odalasvir | DRUG | Participants will receive odalasvir 25 mg tablet, orally. |
| Odalasvir 100 mg | DRUG | Participants will receive odalasvir 2\*50 mg tablet, orally once on Day 1. |
| Placebo | DRUG | Participants will receive odalasvir matching placebo, tablet, orally once on Day 1. |
| Odalasvir 500 mg | DRUG | Participants will receive odalasvir 10\*50 mg tablet, orally once on Day 1. |
| Odalasvir (Up to maximum 1000 mg) | DRUG | Participants will receive odalasvir to be decided up to maximum of 20\*50 mg tablet, orally once on Day 1. |
| AL-335 | DRUG | AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F. |
Inclusion Criteria: * Participant must have a body mass index (BMI: weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 32.0 kilogram per square meter (kg/m\^2), extremes included, and a body weight not less than 50.0 kg * Participant must be healthy on the basis of phys...
Odalasvir is an investigational small molecule being studied in healthy participants and in people with renal insufficiency. It is in Phase 1 clinical development, with completed trials evaluating its pharmacokinetics, safety, and tolerability. Odalasvir is not approved and remains under investigation.
Odalasvir is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. The completed Phase 1 studies focus on pharmacokinetics, safety, and tolerability rather than on a defined target mechanism.
Odalasvir is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company has sponsored multiple Phase 1 clinical trials of Odalasvir in healthy volunteers and in participants with renal insufficiency.
Odalasvir is in Phase 1 clinical development. All four completed trials are Phase 1 studies, and there are no active trials currently enrolling. Odalasvir is investigational and has not been approved by regulatory authorities.
Odalasvir has completed four Phase 1 trials: NCT02821858 in healthy Japanese participants in the United Kingdom, NCT02889367 evaluating cardiac repolarization in the United States, NCT02945020 studying interactions with dabigatran etexilate mesylate, and NCT02961660 in participants with severe renal impairment. All trials are completed.
No, Odalasvir and AL-335 are distinct investigational drugs. In clinical trial NCT02821858, Odalasvir was studied alongside AL-335 to investigate their pharmacokinetics, safety, and tolerability in healthy Japanese participants, but they are separate compounds.