Healthy Subjects
Conditions
Keywords
tolerability, safety
Brief summary
The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects
Interventions
DRUGACT-709478
Hard gelatine capsules for oral administration
DRUGPlacebo
Placebo capsules matching ACT-709478 capsules
DRUGMidazolam
Midazolam oral solution (2 mg/mL) applied with a syringe
DRUGACT-709478 combined with midazolam
Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent form * Healthy male and female subjects aged between 18 and 55 years (inclusive) at screening * Negative serum pregnancy tests at screening and negative urine pregnancy test at Day -1 for women and agreement to use 2 reliable methods of contraception for at least 3 months after last study drug administration * Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening * Systolic blood pressure 100-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 minutes in the supine position at screening and on Day -1 * Healthy on the basis of physical examination, cardiovascular, ophthalmological, neurological assessments and laboratory tests
Exclusion criteria
* Known hypersensitivity to ACT-709478 or drugs of the same class, or any of their excipients * 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 treatments * QT interval corrected with Fridericia's formula (QTcF) \> 450 ms (using the ECG machine HR correction method) at screening and on Day -1 * Treatment with another investigational treatment within 2 months or 5 t1/2 (whichever is the longest) prior to screening or participation in more than four investigational treatment studies within 1 year prior to screening * 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 |
|---|---|---|
| Incidence of treatment-emergent adverse events | up to Day 23 | The percentage of subjects with treatment-emergent adverse events will be reported |
| Changes from baseline in vital signs | up to Day 23 | Vital signs include diastolic and systolic blood pressure and pulse rate |
| Incidence of any clinical relevant findings in ECG variables | up to Day 23 | The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve AUC(tau) of ACT-709478 | up to Day 23 | AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval |
| Maximum plasma concentration (Cmax) of ACT-709478 | up to Day 23 | Cmax is derived from the observed plasma concentration-time curves |
| Time to reach Cmax (tmax) | 24 hours after dosing on Day 1, Day 22 and Day 30 | tmax is directly derived from the observed plasma concentrations |
| Area under the plasma concentration-time curve AUC(tau) of midazolam | 24 hours after dosing on Day 1, Day 22 and Day 30 | AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval |
| Time to reach Cmax (tmax) of ACT-709478 | up to Day 23 | tmax is directly derived from the observed plasma concentrations |
| Terminal half-life (t1/2) of ACT-709478 | up to Day 23 | t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves |
Countries
Germany
Outcome results
None listed