Hepatic ImpairmentPhase 1NCT03713242
A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
A Phase 1 study testing ACT-541468 25 mg and ACT-541468 25 mg (or 10 mg depending on interim results) in people with Hepatic Impairment, run by Idorsia Pharmaceuticals Ltd. at 1 site in Switzerland.
Trial summary
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- ACT-541468 25 mg and ACT-541468 25 mg (or 10 mg depending on interim results)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Feb 2018to 27 Feb 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study-mandated procedure.
- Male and female subjects aged between 18 and 75 years (inclusive) at screening.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (from screening, during the entire study, and for at least one month after last study treatment intake) a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential.
- Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
- For healthy subjects: Normal renal function confirmed by a creatinine clearance at screening according to Cockroft and Gault adjusted to age of:
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- ≥ 80 mL/min/1.73 m2 for subjects ≤ 50 years of age.
- ≥ 70 mL/min/1.73 m2 for subjects 51-60 years of age.
- ≥ 60 mL/min/1.73 m2 for subjects 61-75 years of age.
- For subjects with hepatic impairment: Degree of liver function impairment due to liver cirrhosis according to the Child-Pugh classification:
- Group A: Mild hepatic impairment, Child-Pugh score 5-6.
- Group B: Moderate hepatic impairment, Child-Pugh score 7-9.
- Group C: Severe hepatic impairment, Child-Pugh score 10-15.
Who cannot join
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- For subjects with hepatic impairment: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- For healthy subjects:
- History of alcoholism or drug abuse within the 3-year period prior to screening.
- Relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.
- Conditions
- Hepatic Impairment
- Being tested
- ACT-541468 25 mg, ACT-541468 25 mg (or 10 mg depending on interim results)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-541468 25 mgDrug
Administered as a tablet.
ACT-541468 25 mg (or 10 mg depending on interim results)Drug
Administered as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| Group A: ACT-541468 in subjects with mild hepatic impairment | Experimental | Single oral dose administered on Day 1. Receives: Drug: ACT-541468 25 mg |
| Group B: ACT-541468 in subj. with moderate hepatic impairment | Experimental | Single oral dose administered on Day 1. Receives: Drug: ACT-541468 25 mg (or 10 mg depending on interim results) |
| Group C: ACT-541468 in subjects with severe hepatic impairment | Experimental | Single oral dose administered on Day 1. Receives: Drug: ACT-541468 25 mg (or 10 mg depending on interim results) |
| Group D: ACT-541468 in healthy subjects. | Experimental | Single oral dose administered on Day 1. Receives: Drug: ACT-541468 25 mg (or 10 mg depending on interim results) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (AEs)
Measured: From study treatment administration up to EOS (duration: up to 4 days)
Treatment-emergent serious adverse events (SAEs)
Measured: From study treatment administration up to EOS (duration: up to 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start26 Feb 2018
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
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 Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- prospective, single-center, open-label, single-dose
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT03713242
- Sponsor's protocol ID
- ID-078-112
- Status last verified
- Jul 2020
- First submitted
- 18 Oct 2018
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berger B, Dingemanse J, Sabattini G, Delahaye S, Duthaler U, Muehlan C, Krahenbuhl S. Effect of Liver Cirrhosis on the Pharmacokinetics, Metabolism, and Tolerability of Daridorexant, A Novel Dual Orexin Receptor Antagonist. Clin Pharmacokinet. 2021 Oct;60(10):1349-1360. doi: 10.1007/s40262-021-01028-8. Epub 2021 May 18.
PubMed 34002356
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT03713242
- Acronym / sponsor ID
- ID-078-112
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 19 Oct 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.
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- prospective, single-center, open-label, single-dose
| Arm | Type | Receives |
|---|---|---|
| Group A: ACT-541468 in subjects with mild hepatic impairment | Experimental | Drug: ACT-541468 25 mgSingle oral dose administered on Day 1. |
| Group B: ACT-541468 in subj. with moderate hepatic impairment | Experimental | Drug: ACT-541468 25 mg (or 10 mg depending on interim results)Single oral dose administered on Day 1. |
| Group C: ACT-541468 in subjects with severe hepatic impairment | Experimental | Drug: ACT-541468 25 mg (or 10 mg depending on interim results)Single oral dose administered on Day 1. |
| Group D: ACT-541468 in healthy subjects. | Experimental | Drug: ACT-541468 25 mg (or 10 mg depending on interim results)Single oral dose administered on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent prior to any study-mandated procedure.
- Male and female subjects aged between 18 and 75 years (inclusive) at screening.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (from screening, during the entire study, and for at least one month after last study treatment intake) a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential.
- Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
Key exclusion criteria (5 listed)
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- For subjects with hepatic impairment: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- For healthy subjects:
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-541468 25 mgAdministered as a tablet. | Drug | Group A: ACT-541468 in subjects with mild hepatic impairment |
| ACT-541468 25 mg (or 10 mg depending on interim results)Administered as a tablet. | Drug | Group B: ACT-541468 in subj. with moderate hepatic impairment, Group C: ACT-541468 in subjects with severe hepatic impairment, Group D: ACT-541468 in healthy subjects. |
Primary outcome
Treatment-emergent adverse events (AEs)
Time frame: From study treatment administration up to EOS (duration: up to 4 days)
Treatment-emergent serious adverse events (SAEs)
Time frame: From study treatment administration up to EOS (duration: up to 4 days)
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 2 Jul 2020.
- Derived from this study: PubMed 34002356Berger B, Dingemanse J, Sabattini G, Delahaye S, Duthaler U, Muehlan C, Krahenbuhl S. Effect of Liver Cirrhosis on the Pharmacokinetics, Metabolism, and Tolerability of Daridorexant, A Novel Dual Orexin Receptor Antagonist. Clin Pharmacokinet. 2021 Oct;60(10):1349-1360. doi: 10.1007/s40262-021-01028-8. Epub 2021 May 18.
- 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 ACT-541468 25 mg and ACT-541468 25 mg (or 10 mg depending on interim results) in people with Hepatic Impairment, run by Idorsia Pharmaceuticals Ltd. at 1 site in Switzerland.
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 13 inclusion and 5 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 2 Jul 2020. 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 Switzerland. 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?
Treatment-emergent adverse events (AEs) (time frame: From study treatment administration up to EOS (duration: up to 4 days)). 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?
On the ClinicalTrials.gov record for NCT03713242, 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 2 Jul 2020.