Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALS-008176 · 5 trials · 1 indication
Area under the curve (AUC) of RSV ribonucleic acid (RNA) from nasal swabs immediately prior to 1st dose of study drug (baseline) until Day 7.
Determination of the absolute bioavailability of ALS-008112
Mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae)
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Identical Placebo Comparator |
| ALS-008176 | EXPERIMENTAL | ALS-008176 tablets |
| vehicle alone | PLACEBO_COMPARATOR | Vehicle alone |
| Part 1: Absolute Bioavilability | EXPERIMENTAL | Part 1 of this study is an absolute bioavailability study where the IV (intravenous) microtracer dose of ALS-008112 is administered 15-30 minutes after the oral dose to determine the bioavailability of the oral dose compared to the IV dose. The maximum microtracer IV dose administered in Part 1 of this study will not exceed a single dose of 100 μg \[14C\]-ALS-008112 containing NMT (not more than) 37.0 kBq (1000 nCi) 14C. Based upon previous clinical observations, it is anticipated that the single oral dose and IV microdose to be utilised in Part 1 will provide acceptable PK data and will be safe and well tolerated. |
| Part 2: Mass Balance | EXPERIMENTAL | Part 2 of this study is an absorption, metabolism and excretion study, for which a single 375 mg \[14C\]-ALS-008176 (containing NMT 6.85 MBq (megabecquerel) (185 μCi) 14C) dose has been selected for evaluation based upon data from prior studies. Based upon previous clinical observations, it is anticipated that the dose to be utilised in Part 2 will provide acceptable PK data, will be safe and well tolerated and is within the therapeutic range. |
| ALS-008176 Single Dose | EXPERIMENTAL | Single dose of ALS-008176 administered orally as a suspension |
| Placebo Single Dose | PLACEBO_COMPARATOR | Single dose of placebo administered orally as a suspension |
| ALS-008176 Multiple Doses | EXPERIMENTAL | Multiple doses of ALS-008176 administered orally as a suspension |
| Placebo Multiple Doses | PLACEBO_COMPARATOR | Multiple doses of placebo administered orally as a suspension |
| Name | Type | Description |
|---|---|---|
| ALS-008176 | DRUG | ALS-008176 tablets |
| Placebo | DRUG | Identical placebo tablets |
| vehicle | DRUG | - |
| ALS-008112 | DRUG | - |
Inclusion Criteria: 1. Subject is ≥50 years of age. 2. Female subjects of non-childbearing potential (i.e., surgically sterilized, post-menopausal \[amenorrhea for 1 year confirmed by negative hormone panel\]) who also have a negative pregnancy test at screening. 3. Male subjects must be either sur...
ALS-008176 is an investigational small molecule being developed for the treatment of Respiratory Syncytial Virus (RSV) infections. It is currently in Phase 2 clinical development and has been studied in both healthy volunteers and patients, including infants and adults hospitalized with RSV.
ALS-008176 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company has conducted multiple clinical trials of the drug for Respiratory Syncytial Virus infections.
ALS-008176 is in Phase 2 clinical development. It has completed five clinical trials, including Phase 1 and Phase 2a studies, with a total enrollment of 367 participants. The drug is investigational and has not been approved by regulatory authorities.
ALS-008176 has been studied in five completed clinical trials, including NCT01906164, NCT02202356, NCT02231671, and NCT02673476. These trials evaluated the drug in healthy volunteers and in patients with Respiratory Syncytial Virus infections, including infants and adults.
ALS-008176 is the primary name used in clinical trials and development. No alternative names have been reported for this drug. It is a small molecule being studied for Respiratory Syncytial Virus infections.