Hepatic ImpairmentPhase 1NCT01888393
Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
A Phase 1 study testing lumacaftor 200 mg q12h + ivacaftor 250 mg q12h in people with Hepatic Impairment and Healthy, run by Vertex Pharmaceuticals Incorporated at 2 sites in 2 countries.
Trial summary
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy
- What is being tested?
- lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2013to Nov 2013
- 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
- Group A: Subjects with Moderate Hepatic Impairment
- Male and female 18 to 65 years of age (inclusive)
- Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
- Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.
- Group B: Healthy subjects
- Male and female 18 to 65 years of age (inclusive)
- Healthy subjects with no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
- Willing and able to comply with schedule visits, treatment, laboratory tests, contraceptive guidelines and other study procedures
Who cannot join
- Group A: Subjects with Moderate Hepatic Impairment
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
- Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
- Severe hepatic encephalopathy
- Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
Show all 13Show fewer
- Hepatocellular carcinoma, HIV, hepatitis B/C
- Significant renal dysfunction
- Solid organ or bone marrow transplantation
- History of regular alcohol consumption, drug abuse or regular smoking
- Group B: Healthy subjects
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- History of regular alcohol consumption, drug abuse or regular smoking
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 1, Open Label Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
- Keywords
- pharmacokinetics, hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumacaftor 200 mg q12h + ivacaftor 250 mg q12hDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Approximately 12 subjects (male and female) with moderate hepatic impairment Receives: Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h |
| Group B | Experimental | Approximately 12 healthy subjects (male and female) Receives: Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
Measured: 16 days
Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
Measured: 16 days
Secondary outcomes (3)
Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC
Measured: 16 days
Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC
Measured: 16 days
Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 2013
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 Vertex Pharmaceuticals IncorporatedThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888393
- Sponsor's protocol ID
- VX13-809-010
- Status last verified
- Nov 2013
- First submitted
- 20 Jun 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
- ClinicalTrials.gov ID
- NCT01888393
- Acronym / sponsor ID
- VX13-809-010
- Conditions
- Hepatic Impairment, Healthy
- Keywords
- pharmacokinetics, hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Jun 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 designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12hApproximately 12 subjects (male and female) with moderate hepatic impairment |
| Group B | Experimental | Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12hApproximately 12 healthy subjects (male and female) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Group A: Subjects with Moderate Hepatic Impairment
- Male and female 18 to 65 years of age (inclusive)
- Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
- Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.
- Group B: Healthy subjects
Key exclusion criteria (13 listed)
- Group A: Subjects with Moderate Hepatic Impairment
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
- Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
- Severe hepatic encephalopathy
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 |
|---|---|---|
| lumacaftor 200 mg q12h + ivacaftor 250 mg q12h | Drug | Group A, Group B |
Primary outcome
Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
Time frame: 16 days
Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
Time frame: 16 days
3 secondary outcomes
Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC
Time frame: 16 days
Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC
Time frame: 16 days
Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry
Time frame: 21 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 19 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lumacaftor 200 mg q12h + ivacaftor 250 mg q12h in people with Hepatic Impairment and Healthy, run by Vertex Pharmaceuticals Incorporated at 2 sites in 2 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 8 inclusion and 13 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 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Slovakia. 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?
Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F (time frame: 16 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?
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 Nov 2013.