Healthy Subjects
Conditions
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 male adults
Interventions
DRUGAC-083
Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg
DRUGPlacebo
Placebo capsules matching AC-083 capsules
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent * Healthy on the basis of physical examination, electrocardiogram and laboratory tests. * A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake * Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -1. * Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.
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 cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations * 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 |
|---|---|---|
| Changes from baseline in pulse rate | From baseline to EOS (up to Day 12) | Pulse rate (bpm) |
| Number of participants with adverse events (AEs) | From baseline to end of study (EOS) (up to Day 12) | Treatment-emergent AEs and treatment emergent serious AEs |
| Changes from baseline in supine blood pressure | From baseline to EOS (up to Day 12) | Supine blood pressure (mmHg) |
| Changes from baseline in electrocardiogram (ECG) variables | From baseline to EOS (up to Day 12) | 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 oral ascending doses | From pre-dose on Day 1 to up to Day 12 | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification, from zero to infinity and from zero to 24 h after study drug administration |
| Maximum plasma concentration (Cmax) following single oral ascending doses | From pre-dose on Day 1 to up to Day 12 | Cmax is derived from the observed plasma concentration-time curves |
| Time to reach Cmax (tmax) following single oral ascending doses | From pre-dose on Day 1 to up to Day 12 | Tmax is derived from the observed plasma concentration-time curves |
| Terminal half-life [t(1/2)] following single oral ascending doses | From pre-dose on Day 1 to up to Day 12 | — |
Countries
Germany
Outcome results
None listed