Healthy SubjectsPhase 1NCT03596294
A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan
A Phase 1 study testing Clazosentan, Rifampicin and Saline (0.9% sodium chloride) in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Clazosentan, Rifampicin and Saline (0.9% sodium chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jul 2018to 3 Aug 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 65 years (inclusive) at Screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 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.
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
- Study-specific criteria
- Acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate.
Who cannot join
- Previous exposure to clazosentan.
- Previous exposure to rifampicin within 3 months prior to Screening.
- Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients.
- Known hypersensitivity or allergy to natural rubber latex.
- 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.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
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- Positive results for hepatitis B surface antigen or hepatitis C virus antibody at Screening.
- Positive results from the HIV serology at Screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects
A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan
- Conditions
- Healthy Subjects
- Being tested
- Clazosentan, Rifampicin, Saline (0.9% sodium chloride)
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 15 mg/h of clazosentan for 3 h
RifampicinDrug
Single i.v. dose of 600 mg rifampicin for 30 min
Saline (0.9% sodium chloride)Other
Single i.v infusion of 500 mL saline for 30 min
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence AB | Experimental | Period A:
Saline + clazosentan
Period B:
Rifampicin + clazosentan Receives: Drug: Clazosentan; Drug: Rifampicin; Other: Saline (0.9% sodium chloride) |
| Treatment sequence BA | Experimental | Period B:
Rifampicin + clazosentan
Period A:
Saline + clazosentan Receives: Drug: Clazosentan; Drug: Rifampicin; Other: Saline (0.9% sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from zero to time t of the last measured concentration above the limit of quantification
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: 24 hours post treatment infusion initiation
AUC from zero to infinity (AUC0-inf)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: 24 hours post treatment infusion initiation
AUC from zero to 3 h (AUC0-3)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: 24 hours post treatment infusion initiation
The maximum plasma concentration (Cmax)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: 24 hours post treatment infusion initiation
Terminal half-life (t½)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: 24 hours post treatment infusion initiation
Total body clearance (CL)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: 24 hours post treatment infusion initiation
Volume of distribution at steady state (Vss)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: 24 hours post treatment infusion initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start19 Jul 2018
- Primary completion3 Aug 2018
- Study completion3 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomized, double-blind, two-period, cross-over Phase 1 study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596294
- Sponsor's protocol ID
- ID-054-106
- Other IDs
- 2018-001607-36, 2018
- Status last verified
- Oct 2018
- First submitted
- 5 Jul 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03596294
- Acronym / sponsor ID
- ID-054-106
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 23 Jul 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.
A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, double-blind, two-period, cross-over Phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence AB | Experimental | Drug: Clazosentan, Drug: Rifampicin, Other: Saline (0.9% sodium chloride)Period A: Saline + clazosentan Period B: Rifampicin + clazosentan |
| Treatment sequence BA | Experimental | Drug: Clazosentan, Drug: Rifampicin, Other: Saline (0.9% sodium chloride)Period B: Rifampicin + clazosentan Period A: Saline + clazosentan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 65 years (inclusive) at Screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 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.
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
Key exclusion criteria (9 listed)
- Previous exposure to clazosentan.
- Previous exposure to rifampicin within 3 months prior to Screening.
- Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients.
- Known hypersensitivity or allergy to natural rubber latex.
- 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.
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 15 mg/h of clazosentan for 3 h | Drug | Treatment sequence AB, Treatment sequence BA |
| RifampicinSingle i.v. dose of 600 mg rifampicin for 30 min | Drug | Treatment sequence AB, Treatment sequence BA |
| Saline (0.9% sodium chloride)Single i.v infusion of 500 mL saline for 30 min | Other | Treatment sequence AB, Treatment sequence BA |
Primary outcome
AUC from zero to time t of the last measured concentration above the limit of quantification
Time frame: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to infinity (AUC0-inf)
Time frame: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to 3 h (AUC0-3)
Time frame: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
The maximum plasma concentration (Cmax)
Time frame: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Terminal half-life (t½)
Time frame: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Total body clearance (CL)
Time frame: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Volume of distribution at steady state (Vss)
Time frame: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
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 23 Oct 2018.
- 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, Rifampicin and Saline (0.9% sodium chloride) 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 7 inclusion and 9 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 23 Oct 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?
AUC from zero to time t of the last measured concentration above the limit of quantification (time frame: 24 hours post treatment infusion initiation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2018.