Healthy SubjectsPhase 1NCT03101189
A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing ACT-541468 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ACT-541468
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Mar 2017to 26 Apr 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form;
- Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening;
- Negative serum pregnancy tests at screening and negative urine pregnancy test at Day 1 for women of childbearing potential and agreement to use a reliable method of contraception for at least 90 days after last study drug intake;
- Body mass index (BMI) of 18.0 to 26.0 kg/m2 (inclusive) at screening;
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
- Caucasian or Japanese ethnicity.
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- Japanese subjects only:
- must be of native Japanese descent (all parents/grandparents of Japanese descent);
- must not have been away from Japan for more than 10 years (at screening visit);
- lifestyle should not have changed significantly since relocation from Japan.
Who cannot join
- Any contraindication to the study treatments;
- History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments;
- History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0;
- 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, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-dose ACT-541468 in Healthy Japanese and Caucasian Subjects
So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.
- Conditions
- Healthy Subjects
- Being tested
- ACT-541468, placebo
- Keywords
- safety, Japanese, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-541468Drug
Capsule
placeboDrug
Matching placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| ACT-541468 (25 mg) | Experimental | 8 Japanese and 8 Caucasian subjects will receive 25 mg (1 capsule) of ACT-541468 once daily for 5 days Receives: Drug: ACT-541468 |
| ACT-541468 (50 mg) | Experimental | 8 Japanese and 8 Caucasian subjects will receive 50 mg (2 capsules) of ACT-541468 once daily for 5 days Receives: Drug: ACT-541468 |
| Placebo | Placebo comparator | 2 Japanese / 2 Caucasian subjects will receive 1 placebo capsule to match subjects in the ACT-541468 (25 mg) group and 2 other Japanese / 2 Caucasian subjects will receive 2 placebo capsules to match subjects in the ACT-541468 (50 mg) group Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of ACT-541468
The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling
Measured: From Day1 pre-dose to 48 hours after the last dose on Day 5
Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468
The geometric mean AUC(0-24) values will be calculated based on PK blood sampling
Measured: From Day1 pre-dose to 48 hours after the last dose on Day 5
Secondary outcomes (6)
Time to reach Cmax (tmax) of ACT-541468
The median tmax values will be calculated based on PK blood sampling
Measured: From Day1 pre-dose to 48 hours after the last dose on Day 5
Terminal half-life [t(1/2)] of ACT-541468
The geometric mean t(1/2) values will be calculated based on PK blood sampling
Measured: From Day1 pre-dose to 48 hours after the last dose on Day 5
Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)]
The geometric mean AUC(0-8) values will be calculated based on PK blood sampling
Measured: From Day1 pre-dose to 48 hours after the last dose on Day 5
Incidence of treatment-emergent adverse events
The percentage of subjects with treatment-emergent adverse events will be reported
Measured: Up to Day 7 (end of study)
Incidence of adverse events leading to premature discontinuation of study treatment
The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported
Measured: Up to Day 5
Incidence of any clinical relevant findings in ECG variables
The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported
Measured: Up to Day 7 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start15 Mar 2017
- Primary completion24 Apr 2017
- Study completion26 Apr 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clemens Muehlan, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101189
- Sponsor's protocol ID
- AC-078-105
- Status last verified
- Jul 2018
- First submitted
- 24 Mar 2017
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-dose ACT-541468 in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03101189
- Acronym / sponsor ID
- AC-078-105
- Conditions
- Healthy Subjects
- Keywords
- safety, Japanese, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 5 Apr 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.
So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACT-541468 (25 mg) | Experimental | Drug: ACT-5414688 Japanese and 8 Caucasian subjects will receive 25 mg (1 capsule) of ACT-541468 once daily for 5 days |
| ACT-541468 (50 mg) | Experimental | Drug: ACT-5414688 Japanese and 8 Caucasian subjects will receive 50 mg (2 capsules) of ACT-541468 once daily for 5 days |
| Placebo | Placebo comparator | Drug: placebo2 Japanese / 2 Caucasian subjects will receive 1 placebo capsule to match subjects in the ACT-541468 (25 mg) group and 2 other Japanese / 2 Caucasian subjects will receive 2 placebo capsules to match subjects in the ACT-541468 (50 mg) group |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent form;
- Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening;
- Negative serum pregnancy tests at screening and negative urine pregnancy test at Day 1 for women of childbearing potential and agreement to use a reliable method of contraception for at least 90 days after last study drug intake;
- Body mass index (BMI) of 18.0 to 26.0 kg/m2 (inclusive) at screening;
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
Key exclusion criteria (4 listed)
- Any contraindication to the study treatments;
- History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments;
- History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0;
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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 |
|---|---|---|
| ACT-541468Capsule | Drug | ACT-541468 (25 mg), ACT-541468 (50 mg) |
| placeboMatching placebo capsule | Drug | Placebo |
Primary outcome
Maximum plasma concentration (Cmax) of ACT-541468
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling
Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean AUC(0-24) values will be calculated based on PK blood sampling
6 secondary outcomes
Time to reach Cmax (tmax) of ACT-541468
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Terminal half-life [t(1/2)] of ACT-541468
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)]
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Incidence of treatment-emergent adverse events
Time frame: Up to Day 7 (end of study)
Incidence of adverse events leading to premature discontinuation of study treatment
Time frame: Up to Day 5
Incidence of any clinical relevant findings in ECG variables
Time frame: Up to Day 7 (end of study)
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 10 Jul 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.
Clemens Muehlan study director
Actelion
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 ACT-541468 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 10 inclusion and 4 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 10 Jul 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. Some participants in this study may receive a placebo. 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?
Maximum plasma concentration (Cmax) of ACT-541468 (time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5). The study lists 2 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 10 Jul 2018.