Hepatic ImpairmentPhase 1NCT03114540
Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment
A Phase 1 study testing GBT440 in people with Hepatic Impairment, run by Pfizer at 2 sites in United States.
Trial summary
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- GBT440
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2017to 22 Mar 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects:
- Males or females, 18 to 75 years old
- Willing and able to give written informed consent
- Patients with hepatic impairment:
- Mild hepatic impairment (Child-Pugh A [5-6 points])
- Moderate hepatic impairment (Child-Pugh B [7-9 points])
Show all 10Show fewer
- Severe hepatic impairment (Child-Pugh C [10-15 points])
- Healthy subjects:
- Match in age, gender and body mass index with hepatic impaired subjects
- Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history
Who cannot join
- All subjects:
- Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half-lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device)
- Any signs or symptoms of acute illness at screening or Day -1
- History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Patients with hepatic impairment:
- History of liver transplantation, hepatic mass suggestive of hepatocellular carcinoma or acute liver disease
- Screening serum ALT or AST >5 times the upper limit of normal
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida, 33136
OCRC
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label Study to Characterize the Pharmacokinetics and Safety of a Single Oral Dose of GBT440 in Subjects With Hepatic Impairment
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function.
Read the detailed description
Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
- Conditions
- Hepatic Impairment
- Being tested
- GBT440
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBT440Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| GBT440 Dose 1:Mild hepatic impairment | Experimental | Child Pugh A Receives: Drug: GBT440 |
| GBT440 Dose 1:Moderate hep. impairment | Experimental | Child Pugh B Receives: Drug: GBT440 |
| GBT440 Dose 1:Severe hepatic impairment | Experimental | Child Pugh C Receives: Drug: GBT440 |
| GBT440 Dose 1:Normal hepatic function | Experimental | Healthy subjects Receives: Drug: GBT440 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Maximum observed plasma concentration
Measured: 28 days max
To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Time at which maximum concentration was observed
Measured: 28 days max
To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment
Area under the concentration-time curve
Measured: 28 days max
To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment
Terminal elimination half-life
Measured: 28 days max
Secondary outcomes (5)
Adverse events
Measured: 28 days max
Clinical laboratory tests
Measured: 28 days max
Physical examination findings
Measured: 28 days max
Vital signs
Measured: 28 days max
Electrocardiograms
Measured: 28 days max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start17 Mar 2017
- Primary completion28 Feb 2018
- Study completion22 Mar 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 PfizerThe 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
- Model description
- Multiple-center, nonrandomized, open-label, parallel group study
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114540
- Sponsor's protocol ID
- GBT440-0112
- Other IDs
- C5341047
- Status last verified
- Jul 2023
- First submitted
- 28 Mar 2017
- Last updated
- 18 Jul 2023
- 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 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Characterize the Pharmacokinetics and Safety of a Single Oral Dose of GBT440 in Subjects With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT03114540
- Acronym / sponsor ID
- GBT440-0112
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 14 Apr 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.
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function.
Detailed description
Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multiple-center, nonrandomized, open-label, parallel group study
| Arm | Type | Receives |
|---|---|---|
| GBT440 Dose 1:Mild hepatic impairment | Experimental | Drug: GBT440Child Pugh A |
| GBT440 Dose 1:Moderate hep. impairment | Experimental | Drug: GBT440Child Pugh B |
| GBT440 Dose 1:Severe hepatic impairment | Experimental | Drug: GBT440Child Pugh C |
| GBT440 Dose 1:Normal hepatic function | Experimental | Drug: GBT440Healthy subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females, 18 to 75 years old
- Willing and able to give written informed consent
- Mild hepatic impairment (Child-Pugh A [5-6 points])
- Moderate hepatic impairment (Child-Pugh B [7-9 points])
- Severe hepatic impairment (Child-Pugh C [10-15 points])
Key exclusion criteria (7 listed)
- Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half-lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device)
- Any signs or symptoms of acute illness at screening or Day -1
- History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- History of liver transplantation, hepatic mass suggestive of hepatocellular carcinoma or acute liver disease
- Screening serum ALT or AST >5 times the upper limit of normal
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 |
|---|---|---|
| GBT440Oral | Drug | GBT440 Dose 1:Mild hepatic impairment, GBT440 Dose 1:Moderate hep. impairment, GBT440 Dose 1:Normal hepatic function, GBT440 Dose 1:Severe hepatic impairment |
Primary outcome
To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Time frame: 28 days max
Maximum observed plasma concentration
To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
Time frame: 28 days max
Time at which maximum concentration was observed
To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment
Time frame: 28 days max
Area under the concentration-time curve
To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment
Time frame: 28 days max
Terminal elimination half-life
5 secondary outcomes
Adverse events
Time frame: 28 days max
Clinical laboratory tests
Time frame: 28 days max
Physical examination findings
Time frame: 28 days max
Vital signs
Time frame: 28 days max
Electrocardiograms
Time frame: 28 days max
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 Jul 2023.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
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 GBT440 in people with Hepatic Impairment, run by Pfizer 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 10 inclusion and 7 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 Jul 2023. 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?
To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment (time frame: 28 days max). The study lists 4 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 Jul 2023.