Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACT-128800 · 5 trials · 5 indications
Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Pulse rate was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Body temperature was measured in the supine position using the same thermometer throughout the study.
On Day 1, immediately prior to the intake of study drug, subjects were instructed to empty their bladders. Thereafter, following drug intake all urine produced was collected for 10 days up to Day 11 (morning). Following administration of 14C-ACT-128800, urine samples were collected in three consecutive 8-hour intervals, from 0-8 h, 8-16 h, and 16-24 h. From Day 2 to Day 10 (inclusive), urine samples were collected at 24-hour intervals. In case of an extended observation period, urine samples were also collected at 24-hour intervals. The total amount of radioactivity was measured using a liquid scintillation counter.
Between Day -3 and Day -1, a baseline faeces sample was collected in a light-protected polypropylene box from each subject. From Day 1 (post-dose) to Day 10 (inclusive), all faeces samples and the toilet paper were collected in pre-weighed, light-protected polypropylene boxes. Each faeces sample was collected in a separate box and weighed. The weight of the sample and the time of collection were recorded. All faecal samples were frozen as soon as possible and stored in an upright position at -70 °C or below.The total amount of radioactivity was measured using a liquid scintillation counter.
Blood pressure shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Blood pressure shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Pulse rate shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Body temperature shall be measured in a supine position using the same thermometer throughout the study.
FEV1 assessments shall be performed in a standardized manner as per the American Thoracic Society standards. Three good test breaths will be measured; the highest FEV1 value from these three breath tests will be recorded.
FVC assessments shall be performed in a standardized manner as per the American Thoracic Society standards. Three good test breaths will be measured; the highest FVC value from these three breath tests will be recorded.
Physical examination (i.e., inspection, percussion, palpation, and auscultation) shall be performed during the course of the study.
Heart rate shall be measured using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period.
QTcB shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period. The QTcB interval is the QT interval corrected for heart rate with Bazett's formula (QTcB = QT/RR\^0.5 where RR is 60/heart rate).
QTcF shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period. The QTcF interval is the QT interval corrected for heart rate with Fridericia's formula (QTcF = QT/RR\^0.33 where RR is 60/heart rate).
Electrocardiogram abnormalities shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period.
| Arm | Type | Description |
|---|---|---|
| Investigational drug - Dose 1 | EXPERIMENTAL | - |
| Investigational drug - Dose 2 | EXPERIMENTAL | - |
| Matching placebo | PLACEBO_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | PLACEBO_COMPARATOR | - |
| ACT-128800 | EXPERIMENTAL | ACT-128800 tablets, once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets, once daily, for 18 days |
| Name | Type | Description |
|---|---|---|
| ACT-128800 | DRUG | ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily |
| Placebo | DRUG | ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily |
Inclusion Criteria: * Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment. Exclusion Criteria: * Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than ps...
ACT-128800 is an investigational small molecule being studied for plaque psoriasis, as well as for safety, tolerability, and pharmacokinetics in healthy subjects. It is not approved and remains in clinical development.
ACT-128800 is being developed by Johnson & Johnson (NYSE: JNJ). The company has sponsored clinical trials of the drug in plaque psoriasis and healthy volunteer studies.
ACT-128800 has completed Phase 1 and Phase 2 trials. The most advanced completed trial was a Phase 2 study in plaque psoriasis. The drug is investigational and not FDA approved.
ACT-128800 has completed four trials: NCT00852670 (Phase 2 in plaque psoriasis), NCT02029482 (Phase 1 in healthy subjects), NCT02126956 (Phase 1 mass balance study), and NCT02223832 (Phase 1 in Japanese and Caucasian subjects). All are completed.
No alternative names for ACT-128800 have been reported. It is identified solely by its code name ACT-128800 in clinical trial registries and development records.