Hepatic ImpairmentPhase 1NCT05078580
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
A Phase 1 study testing Iptacopan in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Iptacopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2021to 20 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion in this study met the following key criteria:
- Written informed consent was obtained before performing any assessment.
- Male participants and female participants of non-childbearing potential 18 to 75 years of age (inclusive).
- Participants were to weigh at least 55 kg to participate in the study and were to have a body mass index (BMI) within the range of 18 to 35 kg/m2 for healthy participants.
- For hepatic impairment participants without overt ascites, the BMI was to be within the range of 18 to 40 kg/m2. For hepatic impairment participants with overt ascites, the BMI was to be within the range of 18 to 45 kg/m2.
- Ability to communicate well with the Investigator, to understand and comply with the requirements of the study.
- Participant was willing to remain in the clinical research unit as required by the protocol
Who cannot join
- Participants meeting any of the following criteria were excluded from this study:
- Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing, whichever was longer.
- History of hypersensitivity to the investigational compound/compound class or its excipients being used in this study.
- Pregnant or nursing (lactating) women. Pregnancy was defined as the state of a female after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- Known history of, or current clinically significant arrhythmias, history of prolonged QT correction formula (QTcF) interval or QTcF > 450 msec (males) or QTcF > 460 msec (females) at screening in healthy participants and history of prolonged QTcF interval or QTcF > 470 msec (males) or QTcF > 480 msec (females) at screening in participants with hepatic impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Single Dose, Open-label Study to Investigate the Pharmacokinetics and Safety of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
Read the detailed description
The study comprised of a screening period up to 28 days, one Baseline evaluation on Day -1, a single dose administration of 200 mg of iptacopan followed by PK sampling to 240 hr, and an End-of-Study (EOS) visit (Day 11). All participants had a post study safety follow-up call conducted approximately 30 days after last administration of study drug.
- Conditions
- Hepatic Impairment
- Being tested
- Iptacopan
- Keywords
- LNP023, iptacopan, hepatic impairment, single-dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IptacopanDrug
Also called LNP023
Single oral dose of iptacopan 200 mg oral capsules
IptacopanDrug
Also called LNP023
Single oral dose of iptacopan 200 mg oral capsules
IptacopanDrug
Also called LNP023
Single oral dose of Iptacopan 200 mg oral capsules
IptacopanDrug
Also called LNP023
Single oral dose of Iptacopan 200 mg oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | Iptacopan 200 mg single dose Receives: Drug: Iptacopan |
| Mild hepatic impairment patients | Experimental | Iptacopan 200 mg single dose Receives: Drug: Iptacopan |
| Moderate hepatic impairment patients | Experimental | Iptacopan 200 mg single dose Receives: Drug: Iptacopan |
| Severe hepatic impairment patients | Experimental | Iptacopan 200 mg single dose Receives: Drug: Iptacopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of iptacopan: Cmax The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1)
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Measured: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
Pharmacokinetics parameters of iptacopan: Tmax The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Measured: Day 1 (few time pints), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
Pharmacokinetic parameters of iptacopan: AUClast The AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time × volume-1)
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Measured: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
Pharmacokinetics parameters of iptacopan: AUCinf The AUC from time zero to infinity (mass × time × volume-1)
to assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Measured: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start10 Nov 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078580
- Sponsor's protocol ID
- CLNP023A2105
- Status last verified
- Jul 2023
- First submitted
- 13 Oct 2021
- Last updated
- 24 Jul 2023
- 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Dose, Open-label Study to Investigate the Pharmacokinetics and Safety of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT05078580
- Acronym / sponsor ID
- CLNP023A2105
- Conditions
- Hepatic Impairment
- Keywords
- LNP023, iptacopan, hepatic impairment, single-dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 14 Oct 2021 (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 was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
Detailed description
The study comprised of a screening period up to 28 days, one Baseline evaluation on Day -1, a single dose administration of 200 mg of iptacopan followed by PK sampling to 240 hr, and an End-of-Study (EOS) visit (Day 11). All participants had a post study safety follow-up call conducted approximately 30 days after last administration of study drug.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Drug: IptacopanIptacopan 200 mg single dose |
| Mild hepatic impairment patients | Experimental | Drug: IptacopanIptacopan 200 mg single dose |
| Moderate hepatic impairment patients | Experimental | Drug: IptacopanIptacopan 200 mg single dose |
| Severe hepatic impairment patients | Experimental | Drug: IptacopanIptacopan 200 mg single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent was obtained before performing any assessment.
- Male participants and female participants of non-childbearing potential 18 to 75 years of age (inclusive).
- Participants were to weigh at least 55 kg to participate in the study and were to have a body mass index (BMI) within the range of 18 to 35 kg/m2 for healthy participants.
- For hepatic impairment participants without overt ascites, the BMI was to be within the range of 18 to 40 kg/m2. For hepatic impairment participants with overt ascites, the BMI was to be within the range of 18 to 45 kg/m2.
- Ability to communicate well with the Investigator, to understand and comply with the requirements of the study.
Key exclusion criteria (5 listed)
- Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing, whichever was longer.
- History of hypersensitivity to the investigational compound/compound class or its excipients being used in this study.
- Pregnant or nursing (lactating) women. Pregnancy was defined as the state of a female after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- Known history of, or current clinically significant arrhythmias, history of prolonged QT correction formula (QTcF) interval or QTcF > 450 msec (males) or QTcF > 460 msec (females) at screening in healthy participants and history of prolonged QTcF interval or QTcF > 470 msec (males) or QTcF > 480 msec (females) at screening in participants with hepatic impairment.
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 |
|---|---|---|
| IptacopanAlso: LNP023Single oral dose of iptacopan 200 mg oral capsules | Drug | Healthy participants |
| IptacopanAlso: LNP023Single oral dose of iptacopan 200 mg oral capsules | Drug | Mild hepatic impairment patients |
| IptacopanAlso: LNP023Single oral dose of Iptacopan 200 mg oral capsules | Drug | Moderate hepatic impairment patients |
| IptacopanAlso: LNP023Single oral dose of Iptacopan 200 mg oral capsules | Drug | Severe hepatic impairment patients |
Primary outcome
Pharmacokinetic parameters of iptacopan: Cmax The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1)
Time frame: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Pharmacokinetics parameters of iptacopan: Tmax The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
Time frame: Day 1 (few time pints), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Pharmacokinetic parameters of iptacopan: AUClast The AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time × volume-1)
Time frame: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Pharmacokinetics parameters of iptacopan: AUCinf The AUC from time zero to infinity (mass × time × volume-1)
Time frame: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
to assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
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 24 Jul 2023.
- A Plain Language Trial Summary is available on novctrd.com.Link provided by the sponsor.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Iptacopan in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 1 site in United States.
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 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 24 Jul 2023. 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 United States. 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?
Pharmacokinetic parameters of iptacopan: Cmax The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1) (time frame: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11). The study lists 4 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 24 Jul 2023.