Hepatic ImpairmentPhase 1NCT03369002
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
A Phase 1 study testing seladelpar in people with Hepatic Impairment, run by Gilead Sciences at 4 sites in United States.
Trial summary
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- seladelpar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Nov 2017to 15 May 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have given written informed consent (signed and dated) and any authorizations required by local law.
- Willing to be confined to CRU for the entire duration required by the protocol.
- Male or female, between 18 and 80 years of age.
- Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
- Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.
Who cannot join
- Pregnant or lactating women.
- Treatment with another investigational drug or device within 30 days prior to study drug administration.
- Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
- Inability to swallow medication.
- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
- Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vrg & Noccr
Knoxville, Tennessee, 37920
DaVita Clinical Research
Lakewood, Colorado, 80228
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Seladelpar in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects With Normal Hepatic Function
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- seladelpar
- Keywords
- Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seladelparDrug
Also called MBX-8025
Oral single dose 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Normal | Experimental | Child-Pugh Score: N/A
Subjects will receive a single 10 mg oral dose of seladelpar Receives: Drug: seladelpar |
| Mild Impairment | Experimental | Child-Pugh Score: A (5 to 6 points)
Subjects will receive a single 10 mg oral dose of seladelpar Receives: Drug: seladelpar |
| Moderate Impairment | Experimental | Child-Pugh Score: B (7 to 9 points)
Subjects will receive a single 10 mg oral dose of seladelpar Receives: Drug: seladelpar |
| Severe Impairment | Experimental | Child-Pugh Score: C (10 to 15 points)
Subjects will receive a single 10 mg oral dose of seladelpar Receives: Drug: seladelpar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: 5 days
Time to reach maximum concentration (Tmax)
Measured: 5 days
Area under of the curve (AUC0-t and AUC0-∞)
Measured: 5 days
Elimination of half-life (t1/2)
Measured: 5 days
Apparent terminal elimination rate constant (λz)
Measured: 5 days
Total body clearance (CL/F)
Measured: 5 days
Volume of distribution (Vz/F)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start27 Nov 2017
- Primary completion15 May 2018
- Study completion15 May 2018
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 Gilead SciencesThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369002
- Sponsor's protocol ID
- CB8025-11732
- Status last verified
- May 2018
- First submitted
- 16 Nov 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Seladelpar in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT03369002
- Acronym / sponsor ID
- CB8025-11732
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 11 Dec 2017 (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 Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control 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 | Experimental | Drug: seladelparChild-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar |
| Mild Impairment | Experimental | Drug: seladelparChild-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar |
| Moderate Impairment | Experimental | Drug: seladelparChild-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar |
| Severe Impairment | Experimental | Drug: seladelparChild-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have given written informed consent (signed and dated) and any authorizations required by local law.
- Willing to be confined to CRU for the entire duration required by the protocol.
- Male or female, between 18 and 80 years of age.
- Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
- Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Treatment with another investigational drug or device within 30 days prior to study drug administration.
- Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
- Inability to swallow medication.
- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
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 |
|---|---|---|
| seladelparAlso: MBX-8025Oral single dose 10 mg | Drug | Mild Impairment, Moderate Impairment, Normal, Severe Impairment |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 5 days
Time to reach maximum concentration (Tmax)
Time frame: 5 days
Area under of the curve (AUC0-t and AUC0-∞)
Time frame: 5 days
Elimination of half-life (t1/2)
Time frame: 5 days
Apparent terminal elimination rate constant (λz)
Time frame: 5 days
Total body clearance (CL/F)
Time frame: 5 days
Volume of distribution (Vz/F)
Time frame: 5 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 18 May 2018.
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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.
4 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 seladelpar in people with Hepatic Impairment, run by Gilead Sciences at 4 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 6 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Maximum plasma concentration (Cmax) (time frame: 5 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 18 May 2018.