Healthy SubjectsPhase 1NCT03657446

A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart Function

A Phase 1 study testing Clazosentan and Moxifloxacin in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Clazosentan and Moxifloxacin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteNetherlands
Study dates: 18 Sep 2018to 26 Oct 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

QPS Netherlands B.V.
Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: Randomized, Double-blind (for Clazosentan), Placebo- and Moxifloxacincontrolled, 3-way Cross-over Phase 1 Study to Assess the Effect of Two Intravenous Doses of Clazosentan on the QTc Interval Duration in Healthy Subjects

The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects

Conditions: Healthy Subjects
Being tested: Clazosentan, Placebo, Moxifloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClazosentanDrug
Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
PlaceboDrug
Matching placebo infusion
MoxifloxacinDrug
Film-coated tablet containing 400 mg moxifloxacin

Study groups in NCT03657446
Study group	Role	What they receive
Treatment sequence ABC	Experimental	Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Receives: Drug: Clazosentan; Drug: Placebo; Drug: Moxifloxacin
Treatment sequence ACB	Experimental	Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn Receives: Drug: Clazosentan; Drug: Placebo; Drug: Moxifloxacin
Treatment sequence BAC	Experimental	Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Receives: Drug: Clazosentan; Drug: Placebo; Drug: Moxifloxacin
Treatment sequence BCA	Experimental	Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Receives: Drug: Clazosentan; Drug: Placebo; Drug: Moxifloxacin
Treatment sequence CBA	Experimental	Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Receives: Drug: Clazosentan; Drug: Placebo; Drug: Moxifloxacin
Treatment sequence CAB	Experimental	Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin Receives: Drug: Clazosentan; Drug: Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) with its upper limit of the two-sided 95% confidence interval (CI)
Measured: From 1 hour pre-dose to 24 hour after the end of infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 201826 Oct 2018

First posted5 Sep 2018
Study start18 Sep 2018
Primary completion26 Oct 2018
Study completion26 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: 3-way cross-over Phase 1 study
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03657446
Sponsor's protocol ID: ID-054-107
Other IDs: 2018-002118-12, 2018
Status last verified: Nov 2018
First submitted: 31 Aug 2018
Last updated: 20 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33389549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind (for Clazosentan), Placebo- and Moxifloxacincontrolled, 3-way Cross-over Phase 1 Study to Assess the Effect of Two Intravenous Doses of Clazosentan on the QTc Interval Duration in Healthy Subjects
ClinicalTrials.gov ID: NCT03657446
Acronym / sponsor ID: ID-054-107
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 18 Sep 2018 (actual)
Primary completion: 26 Oct 2018 (actual)
Study completion: 26 Oct 2018 (actual)
First posted: 5 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6
Model description: 3-way cross-over Phase 1 study

Arm	Type	Receives
Treatment sequence ABC	Experimental	Drug: Clazosentan, Drug: Placebo, Drug: MoxifloxacinPeriod A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Treatment sequence ACB	Experimental	Drug: Clazosentan, Drug: Placebo, Drug: MoxifloxacinPeriod A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn
Treatment sequence BAC	Experimental	Drug: Clazosentan, Drug: Placebo, Drug: MoxifloxacinPeriod A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Treatment sequence BCA	Experimental	Drug: Clazosentan, Drug: Placebo, Drug: MoxifloxacinPeriod A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Treatment sequence CBA	Experimental	Drug: Clazosentan, Drug: Placebo, Drug: MoxifloxacinPeriod A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
Treatment sequence CAB	Experimental	Drug: Clazosentan, Drug: Placebo, Drug: MoxifloxacinPeriod A: clazosentan Period B: placebo Period C: placebo + moxifloxacin

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClazosentanContinuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA
PlaceboMatching placebo infusion	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA
MoxifloxacinFilm-coated tablet containing 400 mg moxifloxacin	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA

Primary outcome

Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) with its upper limit of the two-sided 95% confidence interval (CI)
Time frame: From 1 hour pre-dose to 24 hour after the end of infusion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Derived from this study: PubMed 33389549Henrich 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Idorsia Pharmaceuticals Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Clazosentan and Moxifloxacin in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) with its upper limit of the two-sided 95% confidence interval (CI) (time frame: From 1 hour pre-dose to 24 hour after the end of infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03657446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.