Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02673476 | A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus | PHASE2 | COMPLETED | 9 | — | — | Feb 29, 2016 | Oct 31, 2016 | Feb 4, 2025 | 21 | United States, Australia +3 |
| NCT02094365 | A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model | PHASE2 | COMPLETED | 62 | — | — | Mar 1, 2014 | Jul 1, 2014 | Feb 3, 2025 | 1 | United Kingdom |
| NCT02231671 | A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176 | PHASE1 | COMPLETED | 12 | — | — | Aug 31, 2014 | Nov 30, 2014 | Oct 31, 2017 | 1 | United Kingdom |
| NCT02202356 | A Study of ALS-008176 in Infants Hospitalized With RSV | PHASE1 | COMPLETED | 183 | — | — | Jul 23, 2014 | Feb 15, 2018 | Feb 3, 2025 | 77 | United States, Australia +12 |
| NCT01906164 | Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers | PHASE1 | COMPLETED | 101 | — | — | May 31, 2013 | Nov 30, 2013 | Oct 31, 2017 | 1 | France |
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...