Normal Hepatic FunctionPhase 1NCT01764776
Effect of Hepatic Impairment on LDE225..
A Phase 1 study testing LDE225 in people with Normal Hepatic Function and Impaired Hepatic Function, run by Novartis Pharmaceuticals at 5 sites in 5 countries.
Trial summary
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Hepatic Function, Impaired Hepatic Function
- What is being tested?
- LDE225
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Mar 2013to Mar 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and sterile or postmenopausal female age ≥18 to ≤70 years old.
- Normal Vital signs
- Inclusion (group mild, moderate and severe hepatic impairment):
- -Subjects with confirmed cirrhosis
Who cannot join
- Woman of childbearing potential and pregnant or lactating females or male not using condom
- Risk factors for torsades de pointes
- Clinically significant cardio-vascular disease
- severe or uncontrolled medical conditions
- Smokers consuming greater than 10 cigarettes or equivalent nicotine containing products per day.
- Use of investigational drugs (i.e. participation in any clinical investigation)
Show all 9Show fewer
- Symptoms or history of encephalopathy
- Clinical evidence of severe ascites
- -
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
University of Miami Div. of Clinical Pharmacology
Miami, Florida, 33136
About this study
Official title: A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDE225 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Conditions
- Normal Hepatic Function, Impaired Hepatic Function
- Being tested
- LDE225
- Keywords
- LDE225, Pharmacokinetics, PK, Postmenopausal women, normal hepatic function, mild hepatic impairment, moderate hepatic impairment, severe hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDE225Drug
LDE225
| Study group | Role | What they receive |
|---|---|---|
| LDE225 | Experimental | LDE225 Receives: Drug: LDE225 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDE225A pharmacokinetic parameter Tmax
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
Measured: 8 weeks
LDE225A pharmacokinetic parameter Cmax
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
Measured: 8 weeks
LDE225A pharmacokinetic parameter AUClast
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
Measured: 8 weeks
LDE225A pharmacokinetic parameter AUCinf
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
Measured: 8 weeks
LDE225A pharmacokinetic parameter T1/2
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
Measured: 8 weeks
Secondary outcomes (4)
Occurrence of abnormal safety laboratory parameters
Laboratory assessments
Measured: 8 weeks
Plasma protein binding of LDE225
Plasma protein binding of LDE225
Measured: 1 day
Occurrence of changes in ECGs
ECGs
Measured: 8 weeks
Occurrence of adverse event
follow up on any adverse event
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Hepatic FunctionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT01764776
- Sponsor's protocol ID
- CLDE225A2113
- Status last verified
- Jun 2017
- First submitted
- 8 Jan 2013
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDE225 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.
- ClinicalTrials.gov ID
- NCT01764776
- Acronym / sponsor ID
- CLDE225A2113
- Conditions
- Normal Hepatic Function, Impaired Hepatic Function
- Keywords
- LDE225, Pharmacokinetics, PK, Postmenopausal women, normal hepatic function, mild hepatic impairment, moderate hepatic impairment, severe hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Jan 2013 (estimated)
- 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 study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDE225 | Experimental | Drug: LDE225LDE225 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and sterile or postmenopausal female age ≥18 to ≤70 years old.
- Normal Vital signs
- -Subjects with confirmed cirrhosis
Key exclusion criteria (9 listed)
- Woman of childbearing potential and pregnant or lactating females or male not using condom
- Risk factors for torsades de pointes
- Clinically significant cardio-vascular disease
- severe or uncontrolled medical conditions
- Smokers consuming greater than 10 cigarettes or equivalent nicotine containing products per day.
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 |
|---|---|---|
| LDE225LDE225 | Drug | LDE225 |
Primary outcome
LDE225A pharmacokinetic parameter Tmax
Time frame: 8 weeks
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
LDE225A pharmacokinetic parameter Cmax
Time frame: 8 weeks
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
LDE225A pharmacokinetic parameter AUClast
Time frame: 8 weeks
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
LDE225A pharmacokinetic parameter AUCinf
Time frame: 8 weeks
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
LDE225A pharmacokinetic parameter T1/2
Time frame: 8 weeks
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
4 secondary outcomes
Occurrence of abnormal safety laboratory parameters
Time frame: 8 weeks
Plasma protein binding of LDE225
Time frame: 1 day
Occurrence of changes in ECGs
Time frame: 8 weeks
Occurrence of adverse event
Time frame: 8 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 19 Dec 2020.
- Results for CLDE225A2113 from Novartis Clinical Trials websiteLink provided by the sponsor.
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Hepatic Impairment
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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LDE225 in people with Normal Hepatic Function and Impaired Hepatic Function, run by Novartis Pharmaceuticals at 5 sites in 5 countries.
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 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Bulgaria, Germany, Israel. 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?
LDE225A pharmacokinetic parameter Tmax (time frame: 8 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?
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 19 Dec 2020.