A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart Function
NCT ID: NCT03657446
Last Updated: 2018-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2018-09-18
2018-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Treatment sequence ABC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Clazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
Placebo
Matching placebo infusion
Moxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Treatment sequence ACB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn
Clazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
Placebo
Matching placebo infusion
Moxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Treatment sequence BAC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Clazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
Placebo
Matching placebo infusion
Moxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Treatment sequence BCA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Clazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
Placebo
Matching placebo infusion
Moxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Treatment sequence CBA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Clazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
Placebo
Matching placebo infusion
Moxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Treatment sequence CAB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Clazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
Placebo
Matching placebo infusion
Moxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Interventions
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Clazosentan
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
Placebo
Matching placebo infusion
Moxifloxacin
Film-coated tablet containing 400 mg moxifloxacin
Eligibility Criteria
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Inclusion 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
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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QPS Netherlands B.V.
Groningen, , Netherlands
Countries
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References
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Henrich A, Juif PE, Dingemanse J, Krause A. PK/PD modeling of a clazosentan thorough QT study with hysteresis in concentration-QT and RR-QT. J Pharmacokinet Pharmacodyn. 2021 Apr;48(2):213-224. doi: 10.1007/s10928-020-09728-7. Epub 2021 Jan 2.
Other Identifiers
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2018-002118-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ID-054-107
Identifier Type: -
Identifier Source: org_study_id
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