Healthy SubjectsPhase 1NCT03339752

A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin

A Phase 1 study testing Rosuvastatin and ACT-541468 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.

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

A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin Read more about this study

Who is it for?: Ages 18 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Rosuvastatin and ACT-541468
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteCzechia
Study dates: 30 Oct 2017to 2 Dec 2017
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 64 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Signed informed consent in the local language prior to any study mandated procedure;
Healthy male subjects aged 18 to 45 years (inclusive) at screening;
Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Who cannot join

Known allergic reactions or hypersensitivity to ACT-541468, rosuvastatin, any drug of the same classes, or any of their excipients;
Any contraindication for rosuvastatin treatment;
History or clinical evidence of myopathy;
Asian or Indian-Asian ethnicity;
Known hypersensitivity or allergy to natural rubber latex;
Previous exposure to ACT-541468;
Treatment with rosuvastatin within 3 months 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.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

Cepha s.r.o.
Pilsen, 32300

Other trials in Czechia

About this study

Official title: A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-541468 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects

A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin

Conditions: Healthy Subjects
Being tested: Rosuvastatin, ACT-541468

What participants receive

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

RosuvastatinDrug
10 mg tablet
ACT-541468Drug
25 mg hard capsule

Study groups in NCT03339752
Study group	Role	What they receive
Treatment A	Active comparator	Rosuvastatin Day 1 Receives: Drug: Rosuvastatin
Treatment B1	Experimental	ACT-541468 Day 5 to Day 7 Receives: Drug: ACT-541468
Treatment B2	Other	Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12 Receives: Drug: Rosuvastatin; Drug: ACT-541468

What is being measured

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

Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
Measured: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
Measured: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
Measured: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
Measured: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin
Measured: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.

Secondary outcomes (7)

Trough concentration (Ctrough) of ACT-541468
Trough concentration (Ctrough) of ACT-541468
Measured: During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week
Change in vital signs
Change from baseline to each time point of measurement during each treatment in vital signs (supine BP and pulse rate)
Measured: From Screening to EOS (for a maximum of up to 5 weeks)
Change in ECG variables
Change from baseline to each time point of measurement during each treatment in ECG variables
Measured: From Screening to EOS (for a maximum of up to 5 weeks)
Treatment-emergent (serious) adverse events
Treatment-emergent AEs and SAEs during each treatment
Measured: From Screening to EOS (for a maximum of up to 5 weeks)
Treatment-emergent ECG abnormalities
Treatment-emergent ECG abnormalities during each treatment
Measured: From Screening to EOS (for a maximum of up to 5 weeks)
Change in body weight
Change from baseline to each time point of measurement during each treatment in body weight
Measured: From Screening to EOS (for a maximum of up to 5 weeks)
Change in clinical laboratory tests
Change from baseline to each time point of measurement during each treatment in clinical laboratory tests
Measured: From Screening to EOS (for a maximum of up to 5 weeks)

Timeline

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

30 Oct 20172 Dec 2017

First posted13 Nov 2017
Study start30 Oct 2017
Primary completion2 Dec 2017
Study completion2 Dec 2017

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: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03339752
Sponsor's protocol ID: ID-078-106
Status last verified: Dec 2017
First submitted: 26 Oct 2017
Last updated: 11 Dec 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-541468 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03339752
Acronym / sponsor ID: ID-078-106
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 30 Oct 2017 (actual)
Primary completion: 2 Dec 2017 (actual)
Study completion: 2 Dec 2017 (actual)
First posted: 13 Nov 2017 (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 ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment A	Active comparator	Drug: RosuvastatinRosuvastatin Day 1
Treatment B1	Experimental	Drug: ACT-541468ACT-541468 Day 5 to Day 7
Treatment B2	Other	Drug: Rosuvastatin, Drug: ACT-541468Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12

Who may qualify

Ages: 18 to 64 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Signed informed consent in the local language prior to any study mandated procedure;
Healthy male subjects aged 18 to 45 years (inclusive) at screening;
Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Key exclusion criteria (8 listed)

Known allergic reactions or hypersensitivity to ACT-541468, rosuvastatin, any drug of the same classes, or any of their excipients;
Any contraindication for rosuvastatin treatment;
History or clinical evidence of myopathy;
Asian or Indian-Asian ethnicity;
Known hypersensitivity or allergy to natural rubber latex;

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
Rosuvastatin10 mg tablet	Drug	Treatment A, Treatment B2
ACT-54146825 mg hard capsule	Drug	Treatment B1, Treatment B2

Primary outcome

Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin
Time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin

7 secondary outcomes

Trough concentration (Ctrough) of ACT-541468
Time frame: During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week
Change in vital signs
Time frame: From Screening to EOS (for a maximum of up to 5 weeks)
Change in ECG variables
Time frame: From Screening to EOS (for a maximum of up to 5 weeks)
Treatment-emergent (serious) adverse events
Time frame: From Screening to EOS (for a maximum of up to 5 weeks)
Treatment-emergent ECG abnormalities
Time frame: From Screening to EOS (for a maximum of up to 5 weeks)
Change in body weight
Time frame: From Screening to EOS (for a maximum of up to 5 weeks)
Change in clinical laboratory tests
Time frame: From Screening to EOS (for a maximum of up to 5 weeks)

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 11 Dec 2017.
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.

Clemens Mühlan 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 Rosuvastatin and ACT-541468 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.

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 4 inclusion and 8 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 11 Dec 2017. 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 Czechia. 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?

Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin (time frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.). The study lists 5 primary outcomes in all. 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 NCT03339752.

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 11 Dec 2017.