Healthy Subjects
Conditions
Brief summary
The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects
Interventions
DRUGClazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
DRUGPlacebo
Matching placebo infusion
DRUGMoxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
3-way cross-over Phase 1 study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
General criteria * Signed informed consent prior to any study-mandated procedure * Body mass index of 18.0-30.0 kg/m2 (inclusive) at Screening * Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period * 12-lead ECG: QT interval corrected using Fridericia's formula (QTcF) \<450 ms for male subjects and \< 470 ms for female subjects, QRS interval \< 110 ms, PR interval ≤ 200 ms, and heart rate (HR) ≤ 90 bpm without clinically relevant abnormalities using a 12-lead ECG measured after 5 min in the supine position at Screening and on Day -1 of the first Period Study-specific criteria * Women of non-childbearing potential * Male subjects must accept to use a condom and not to procreate for the duration of the study and for 3 months thereafter
Exclusion criteria
General criteria * Previous exposure to clazosentan or to moxifloxacin within 3 months prior to Screening * Known hypersensitivity to any of clazosentan excipients or to moxifloxacin or any of its excipients * Any contraindication to moxifloxacin treatment * Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions if considered clinically significant by the investigator * Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture) * Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical 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 Study-specific criteria • History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) with its upper limit of the two-sided 95% confidence interval (CI) | From 1 hour pre-dose to 24 hour after the end of infusion |
Countries
Netherlands
Outcome results
None listed