Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALS-008176 · 2 trials · 2 indications
Change from baseline in QTc intervals with Fredericia correction will be analyzed.
The Cmax is the maximum observed plasma concentration of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
The Tmax is the time to reach the maximum observed plasma concentration of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
Time of last measurable (non-below quantification limit \[non-BQL\]) plasma concentration.
The AUC (0-last) is the area under the plasma ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time 0 to time of the last observed (non-BQL) quantifiable concentration, calculated by linear-linear trapezoidal summation.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed (non-BQL) quantifiable concentration and lambda(z) is elimination rate constant. Extrapolations of more than 20.00% of the total AUC are reported as approximations.
The %AUC\[infinity,ex\] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC\[0-infinity\] - AUC\[0-last\])\*100/AUC\[0-infinity\].
The Lambda (alpha) determined by linear regression of the first elimination phase of the ln-linear plasma concentration-time curve.
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
The t(1/2alpha) is defined as 0.693/Lambda (alpha).
The t(1/2term) is defined as 0.693/Lambda (z).
Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.
Total amount excreted into urine, calculated by adding the amounts of the individual intervals together {Ae\[0-48hours(h)\]}.
Total percentage of the dose excreted into urine, calculated as 100 \* (Ae\[total\]/Dose).
Renal clearance calculated as Ae (0-48h)/AUC (0-48h).
| Arm | Type | Description |
|---|---|---|
| Part 1: Group 1 | EXPERIMENTAL | Participants will receive Treatment A (a single dose of ALS-008176 1,500 mg) or Treatment B (a single dose of placebo) under fasted conditions. |
| Part 1: Group 2 | EXPERIMENTAL | Participants will receive Treatment C (a single dose of ALS-008176 2,500 mg) or Treatment D (a single dose of placebo) under fasted conditions. |
| Part 1: Group 3 | EXPERIMENTAL | Participants will receive Treatment E (a single dose of ALS-008176 3,000 mg) or Treatment F (a single dose of placebo) under fasted conditions. |
| Part 2: Sequence GHI | EXPERIMENTAL | Participants will receive Treatment G (a single dose of ALS-008176 3,000 mg + a single dose of moxifloxacin placebo under fasted conditions) then Treatment H (a single dose of ALS-008176 placebo + a single dose of moxifloxacin 400 mg under fasted conditions) then Treatment I (a single dose of ALS-008176 placebo + a single dose of moxifloxacin placebo under fasted conditions). There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence HIG | EXPERIMENTAL | Participants will receive Treatment H then Treatment I and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence IGH | EXPERIMENTAL | Participants will receive Treatment I then Treatment G and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence IHG | EXPERIMENTAL | Participants will receive Treatment I then Treatment H and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence HGI | EXPERIMENTAL | Participants will receive Treatment H then Treatment G and then Treatment I. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence GIH | EXPERIMENTAL | Participants will receive Treatment G then Treatment I and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. |
| ALS-008176 (250 mg) or Placebo | EXPERIMENTAL | Participants will receive ALS-008176, 250 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (500 mg) or Placebo | EXPERIMENTAL | Participants will receive ALS-008176, 500 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (750 mg) or Placebo | EXPERIMENTAL | Participants will receive ALS-008176, 750 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| ALS-008176 | DRUG | Participants will receive a single dose of ALS-008176 orally. |
| Placebo | DRUG | Matching Placebo will be administered. |
| Moxifloxacin | DRUG | Participants will receive a single dose of moxifloxacin 400 mg. |
| ALS-008176 (250 mg) | DRUG | Participants will receive ALS-008176, 250 mg oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (500 mg) | DRUG | Participants will receive ALS-008176, 500 mg oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (750 mg) | DRUG | Participants will receive ALS-008176, 750 mg oral suspension once on Day 1 under fasted conditions. |
Inclusion Criteria: * Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study * Participant must be willing and able to adhere to the prohibitions and restrictions...
ALS-008176 is an investigational small molecule being studied for Respiratory Syncytial Virus (RSV) infections and in healthy participants. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being evaluated for safety, tolerability, and pharmacokinetics.
ALS-008176 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting Phase 1 clinical trials to evaluate the drug's safety and effects in healthy participants.
ALS-008176 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with no active trials currently ongoing.
ALS-008176 has been studied in two completed Phase 1 trials. NCT02478333 evaluated safety, tolerability, and pharmacokinetics in healthy Japanese adults with RSV infections. NCT02833831 assessed the drug's effect on cardiac repolarization in healthy participants in the United States.
No alternative names for ALS-008176 have been disclosed. The drug is identified solely by its code name ALS-008176 in clinical trial records and development documentation.