Normal Hepatic FunctionPhase 1NCT01950481
Effect of Hepatic Impairment on LDK378 Pharmacokinetics
A Phase 1 study testing LDK378 in people with Normal Hepatic Function and Impaired Hepatic Function, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
Pharmacokinetics and safety of 750 mg of LDK378 given once orally 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 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Hepatic Function, Impaired Hepatic Function
- What is being tested?
- LDK378
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to Sep 2016
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male Subjects between 18-70 years of age
- Female subjects between 18-70 years of age who are postmenopausal or sterile
- Body Mass Index (BMI) of 18.0- 36.0 kg/m2, with body weight ≥ 50 kg.
- Inclusion (group mild, moderate and severe hepatic impairment):
- Subjects with confirmed cirrhosis
Who cannot join
- impaired cardiac function
- concurrent severe and/or uncontrolled medical conditions
- Clinical evidence of severe ascites
- Use of PPIs within 10 days prior to 2 days after LDK378 dosing
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Avail. Clinical Research, LLC
DeLand, Florida, 32720
DaVita Clinical Research-Denver
Lakewood, Colorado, 80228
Clinical Research of Miami, INC CLDK378A2110
Miami, Florida, 33126
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32086
About this study
Official title: A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDK378 in Subjects With Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Conditions
- Normal Hepatic Function, Impaired Hepatic Function
- Being tested
- LDK378
- Keywords
- LDK378, pharmacokinetics, hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDK378Drug
Oral LDK378 750 mg once
| Study group | Role | What they receive |
|---|---|---|
| Normal Hepatic Function | Experimental | Subjects with normal hepatic function Receives: Drug: LDK378 |
| Mild Hepatic Impairment | Experimental | Subjects with mild hepatic impairment Receives: Drug: LDK378 |
| Moderate Hepatic Impairment | Experimental | Subjects with moderate hepatic impairment Receives: Drug: LDK378 |
| Severe Hepatic Impairment | Experimental | Subjects with severe hepatic impairment Receives: Drug: LDK378 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDK378 pharmacokinetic parameters (Tmax)
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Measured: 18 Days
LDK378 pharmacokinetic parameters ( Cmax)
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Measured: 18 Days
LDK378 pharmacokinetic parameters ( AUClast)
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Measured: 18 Days
LDK378 pharmacokinetic parameters (AUCinf)
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Measured: 18 Days
LDK378 pharmacokinetic parameters (T1/2)
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Measured: 18 Days
LDK378 pharmacokinetic parameters (CL/F)
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Measured: 18 Days
LDK378 pharmacokinetic parameters (Vz/F)
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Measured: 18 Days
Secondary outcomes (2)
Number of subjects with Adverse events
Safety will be determined by the frequency of adverse events and the frequency of laboratory toxicities.
Measured: after informed consent is signed, 30 days after last dose
Plasma protein binding of LDK378
Plasma protein binding of LDK378
Measured: Day 1 predose, Day 1 6 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionSep 2016
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01950481
- Sponsor's protocol ID
- CLDK378A2110
- Status last verified
- Dec 2016
- First submitted
- 23 Sep 2013
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 LDK378 in Subjects With Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT01950481
- Acronym / sponsor ID
- CLDK378A2110
- Conditions
- Normal Hepatic Function, Impaired Hepatic Function
- Keywords
- LDK378, pharmacokinetics, hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Sep 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.
Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Hepatic Function | Experimental | Drug: LDK378Subjects with normal hepatic function |
| Mild Hepatic Impairment | Experimental | Drug: LDK378Subjects with mild hepatic impairment |
| Moderate Hepatic Impairment | Experimental | Drug: LDK378Subjects with moderate hepatic impairment |
| Severe Hepatic Impairment | Experimental | Drug: LDK378Subjects with severe hepatic impairment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male Subjects between 18-70 years of age
- Female subjects between 18-70 years of age who are postmenopausal or sterile
- Body Mass Index (BMI) of 18.0- 36.0 kg/m2, with body weight ≥ 50 kg.
- Subjects with confirmed cirrhosis
Key exclusion criteria (4 listed)
- impaired cardiac function
- concurrent severe and/or uncontrolled medical conditions
- Clinical evidence of severe ascites
- Use of PPIs within 10 days prior to 2 days after LDK378 dosing
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 |
|---|---|---|
| LDK378Oral LDK378 750 mg once | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function, Severe Hepatic Impairment |
Primary outcome
LDK378 pharmacokinetic parameters (Tmax)
Time frame: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters ( Cmax)
Time frame: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters ( AUClast)
Time frame: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (AUCinf)
Time frame: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (T1/2)
Time frame: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (CL/F)
Time frame: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (Vz/F)
Time frame: 18 Days
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
2 secondary outcomes
Number of subjects with Adverse events
Time frame: after informed consent is signed, 30 days after last dose
Plasma protein binding of LDK378
Time frame: Day 1 predose, Day 1 6 hours postdose
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 CLDK378A2110 can be found on the Novartis Clinical Trial Results 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LDK378 in people with Normal Hepatic Function and Impaired Hepatic Function, run by Novartis Pharmaceuticals at 5 sites 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 5 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 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. 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?
LDK378 pharmacokinetic parameters (Tmax) (time frame: 18 Days). The study lists 7 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.