A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart Function
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT03657446
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence ACB Placebo Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn Treatment sequence CAB Placebo Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence ABC Placebo Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence BAC Placebo Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence BCA Placebo Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence CBA Placebo Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence ACB Clazosentan Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn Treatment sequence ABC Clazosentan Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence ABC Moxifloxacin Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence ACB Moxifloxacin Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn Treatment sequence BAC Moxifloxacin Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence BCA Moxifloxacin Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence CBA Moxifloxacin Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence CAB Moxifloxacin Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence BAC Clazosentan Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence BCA Clazosentan Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence CBA Clazosentan Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Treatment sequence CAB Clazosentan Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
QPS Netherlands B.V.
🇳🇱Groningen, Netherlands