Healthy Subjects
Conditions
Keywords
healthy subjects, first-in-man, safety
Brief summary
The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults
Interventions
DRUGAC-082
Hard gelatin capsules for oral administration
DRUGPlacebo
Matched placebo capsules for oral administration
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Key inclusion Criteria: * Signed informed consent * Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests * Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive) * Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1 * Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive) * Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 90-140 mmHg, 50-90 mmHg and 50-90 bpm (all inclusive), respectively Key
Exclusion criteria
* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions * Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to end of study (up to Day 11) | Treatment-emergent adverse events and treatment-emergent serious adverse events |
| Changes from baseline in vital signs | Up to end of study (up to Day 11) | Vital signs include diastolic and systolic blood pressure and pulse rate |
| Changes from baseline in ECG variables | Up to end of study (up to day 11) | ECG variables are to be recorded at rest using a standard 12-lead ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) following single ascending doses | From pre-dose on Day 1 to 96 hours post dose | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification \[AUC(0-t)\] and from zero to infinity \[AUC(0-inf)\] |
| Maximum plasma concentration (Cmax) following multiple ascending doses | Up to 96 hours following the last dose administration on Day 4 | — |
| Maximum plasma concentration (Cmax) following single ascending doses | From pre-dose on Day 1 to 96 hours post dose | Cmax is derived from the observed plasma concentration-time curves |
| Terminal half-life [t(1/2)] following multiple ascending doses | Up to 96 hours following the last dose administration on Day 4 | t(1/2) on the last day of dosing |
| Area under the plasma concentration-time curve during a dosing interval (AUCtau) | Day 1 and Day 4 | AUCtau is the area under the plasma concentration-time curve during a dosing interval |
| Time to reach Cmax (tmax) following multiple ascending doses | Up to 96 hours following the last dose administration on Day 4 | — |
| Time to reach Cmax (tmax) following single ascending doses | From pre-dose on Day 1 to 96 hours post dose | tmax is derived from the observed plasma concentration-time curves |
| Terminal half-life [t(1/2)] following single ascending doses | From pre-dose on Day 1 to 96 hours post dose | — |
Countries
Germany
Outcome results
None listed