Hepatic ImpairmentPhase 1NCT03048448
Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects
A Phase 1 study testing Fevipiprant in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of QAW039 in patients with hepatic impairment compared to healthy matched control subjects. 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
- What is being tested?
- Fevipiprant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 May 2017to 22 Apr 2019
- 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
- All subjects
- Weight of at least 50 kg and no more than 120 kg and have a body mass index in the range 18.0-36.0 kg/m2
- Patients with hepatic impairment
- Moderate hepatic impairment (Group 1): Child-Pugh Class B (7-9 points),
- Severe hepatic impairment (Group 2): Child-Pugh Class C (10-15 points
- Mild hepatic impairment (Group 4): Child-Pugh Class A (5-6 points)
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- Healthy subjects
- Match in age (±5 years), gender, smoking status, and weight (± 15%) to an individual patient.
- In good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis at screening.
Who cannot join
- All subjects
- History of hypersensitivity and/or idiosyncracies to QAW039 or to drugs of similar classes (CRTh2 antagonists).
- Use of co-medications that may impact QAW039 exposure such as broad range UGT inhibitors or strong inhibitors of OAT3, OATP1B3, and P-gp, including but not limited to probenecid, ritonavir, valproic acid, and rifampin
- Surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Pregnant or nursing (lactating) women.
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- Women of child-bearing potential
- Patients with hepatic impairment
- Hepatic impairment due to non-liver disease (e.g., right heart failure)
- Current symptoms or history of encephalopathy Grade III or IV within the past 6 months
- Primary biliary liver cirrhosis and biliary obstruction
- Emergency room visit or hospitalization due to liver disease within the preceding 3 months.
- Severe complications of liver disease within the preceding 3 months.
- Healthy subjects
- Liver disease or liver injury as indicated by abnormal liver function tests.
- Any single parameter of ALT, AST, γ-GT, alkaline phosphatase or serum bilirubin must not exceed 1.5 x upper limit of normal (ULN)
- Any elevation above ULN of more than one parameter of ALT, AST, γ GT, alkaline phosphatase or serum bilirubin will exclude a subject from participation in the study
- A positive Hepatitis B surface antigen or Hepatitis C test result.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novartis Investigative Site
Anaheim, California, 92801
Novartis Investigative Site
Orlando, Florida, 32809
About this study
Official title: An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects
This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of QAW039 in patients with hepatic impairment compared to healthy matched control subjects.
Read the detailed description
The purpose of this study is to determine if the pharmacokinetic profile of Fevipiprant is different in patients with hepatic impairment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information.
- Conditions
- Hepatic Impairment
- Being tested
- Fevipiprant
- Keywords
- Hepatic impairment,, Fevipiprant,, adults,, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FevipiprantDrug
Also called QAW039
Single 450mg dose
| Study group | Role | What they receive |
|---|---|---|
| Fevipiprant 450mg | Experimental | 450mg Film Coated Tablet Receives: Drug: Fevipiprant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Plasma concentration of Fevipiprant by AUClast
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Measured: 120 hours post-dose
Pharmacokinetics: Plasma concentration of Fevipiprant by AUCinf
AUCinf is the area under the plasma concentration-time curve from time zero to infinity
Measured: 120 hours post-dose
Pharmacokinetics: Plasma concentration of Fevipiprant by Cmax
Cmax is the observed maximum plasma concentration following drug administration
Measured: 120 hours post-dose
Secondary outcomes (6)
Relationship between plasma pharmacokinetics of Fevipiprant by AUClast and baseline hepatic function.
AUClast (the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ) related to Child Pugh score
Measured: 120 hours post-dose
Relationship between plasma pharmacokinetics of Fevipiprant by AUCinf and baseline hepatic function.
AUCinf (the area under the plasma concentration-time curve from time zero to infinity) related to Child Pugh score
Measured: 120 hours post-dose
Relationship between plasma pharmacokinetics of Fevipiprant by Cmax and baseline hepatic function.
Cmax is the observed maximum plasma concentration following drug administration related to Child Pugh score
Measured: 120 hours post-dose
Pharmacokinetics of the metabolite CCN362 by AUClast
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Measured: 120 hours post-dose
Pharmacokinetics of the metabolite CCN362 by AUCinf
AUCinf is the area under the plasma concentration-time curve from time zero to infinity
Measured: 120 hours post-dose
Pharmacokinetics of the metabolite CCN362 by Cmax
Cmax is the observed maximum plasma concentration following drug administration
Measured: 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start31 May 2017
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT03048448
- Sponsor's protocol ID
- CQAW039A2108
- Status last verified
- Apr 2020
- First submitted
- 27 Jan 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects
- ClinicalTrials.gov ID
- NCT03048448
- Acronym / sponsor ID
- CQAW039A2108
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic impairment,, Fevipiprant,, adults,, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 9 Feb 2017 (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 will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of QAW039 in patients with hepatic impairment compared to healthy matched control subjects.
Detailed description
The purpose of this study is to determine if the pharmacokinetic profile of Fevipiprant is different in patients with hepatic impairment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fevipiprant 450mg | Experimental | Drug: Fevipiprant450mg Film Coated Tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All subjects
- Weight of at least 50 kg and no more than 120 kg and have a body mass index in the range 18.0-36.0 kg/m2
- Patients with hepatic impairment
- Moderate hepatic impairment (Group 1): Child-Pugh Class B (7-9 points),
- Severe hepatic impairment (Group 2): Child-Pugh Class C (10-15 points
Key exclusion criteria (18 listed)
- All subjects
- History of hypersensitivity and/or idiosyncracies to QAW039 or to drugs of similar classes (CRTh2 antagonists).
- Use of co-medications that may impact QAW039 exposure such as broad range UGT inhibitors or strong inhibitors of OAT3, OATP1B3, and P-gp, including but not limited to probenecid, ritonavir, valproic acid, and rifampin
- Surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
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 |
|---|---|---|
| FevipiprantAlso: QAW039Single 450mg dose | Drug | Fevipiprant 450mg |
Primary outcome
Pharmacokinetics: Plasma concentration of Fevipiprant by AUClast
Time frame: 120 hours post-dose
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Pharmacokinetics: Plasma concentration of Fevipiprant by AUCinf
Time frame: 120 hours post-dose
AUCinf is the area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics: Plasma concentration of Fevipiprant by Cmax
Time frame: 120 hours post-dose
Cmax is the observed maximum plasma concentration following drug administration
6 secondary outcomes
Relationship between plasma pharmacokinetics of Fevipiprant by AUClast and baseline hepatic function.
Time frame: 120 hours post-dose
Relationship between plasma pharmacokinetics of Fevipiprant by AUCinf and baseline hepatic function.
Time frame: 120 hours post-dose
Relationship between plasma pharmacokinetics of Fevipiprant by Cmax and baseline hepatic function.
Time frame: 120 hours post-dose
Pharmacokinetics of the metabolite CCN362 by AUClast
Time frame: 120 hours post-dose
Pharmacokinetics of the metabolite CCN362 by AUCinf
Time frame: 120 hours post-dose
Pharmacokinetics of the metabolite CCN362 by Cmax
Time frame: 120 hours post-dose
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 11 Dec 2020.
- Results for CQAW039A2108 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
2 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 Fevipiprant in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 2 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 9 inclusion and 18 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 11 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 2 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?
Pharmacokinetics: Plasma concentration of Fevipiprant by AUClast (time frame: 120 hours post-dose). The study lists 3 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 11 Dec 2020.