Renal ImpairmentPhase 1NCT03161015
Single-Dose PK Study of GBT440 in Subjects With Renal Impairment
A Phase 1 study testing GBT440 in people with Renal Impairment, run by Global Blood Therapeutics 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, moderate, or severe renal impairment disease and healthy subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal 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
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2016to 6 Jul 2017
- 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
- All subjects:
- Males or females, 18 to 80 years old
- Willing and able to give written informed consent
- Subjects with renal impairment:
- Severe renal impairment (eGFR < 30 mL/min/1.73m2, not on dialysis)
- Moderate renal impairment (30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2)
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- Mild renal impairment (60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2)
- Healthy subjects:
- Match in age, gender and body mass index with renal 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
- Subjects with renal impairment:
- History of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year
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 Non-Randomized, Open-Label, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics of GBT440 in Subjects With Renal Impaired Function to Healthy Subjects
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.
Read the detailed description
Up to 40 adult subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
- Conditions
- Renal Impairment
- Being tested
- GBT440
- Medical subject headings
- Renal Insufficiency
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: Severe Renal Impairment | Experimental | eGFR < 30 mL/min/1.73m2, not on dialysis Receives: Drug: GBT440 |
| GBT440 Dose 1: Moderate Renal Impairment | Experimental | 30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2 Receives: Drug: GBT440 |
| GBT440 Dose 1: Mild Renal Impairment | Experimental | 60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2 Receives: Drug: GBT440 |
| GBT440 Dose 1: Normal Renal function | Experimental | eGFR > or = 90 mL/min/1.73m2 Receives: Drug: GBT440 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Maximum observed plasma concentration
Measured: 28 days max
Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Measured: 28 days max
AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Measured: 28 days max
T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Measured: 28 days max
Secondary outcomes (1)
Number of subjects with treatment-related Adverse events
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 posted19 May 2017
- Study startNov 2016
- Primary completion25 May 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Blood Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carla Washington, Study director, Global Blood Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161015
- Sponsor's protocol ID
- GBT440-0110
- Status last verified
- Feb 2018
- First submitted
- 8 May 2017
- Last updated
- 22 Feb 2018
- 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 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics of GBT440 in Subjects With Renal Impaired Function to Healthy Subjects
- ClinicalTrials.gov ID
- NCT03161015
- Acronym / sponsor ID
- GBT440-0110
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Global Blood TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 19 May 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, moderate, or severe renal impairment disease and healthy subjects with normal renal function.
Detailed description
Up to 40 adult 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: Severe Renal Impairment | Experimental | Drug: GBT440eGFR < 30 mL/min/1.73m2, not on dialysis |
| GBT440 Dose 1: Moderate Renal Impairment | Experimental | Drug: GBT44030 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2 |
| GBT440 Dose 1: Mild Renal Impairment | Experimental | Drug: GBT44060 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2 |
| GBT440 Dose 1: Normal Renal function | Experimental | Drug: GBT440eGFR > or = 90 mL/min/1.73m2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females, 18 to 80 years old
- Willing and able to give written informed consent
- Severe renal impairment (eGFR < 30 mL/min/1.73m2, not on dialysis)
- Moderate renal impairment (30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2)
- Mild renal impairment (60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2)
Key exclusion criteria (6 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 clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year
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 Renal Impairment, GBT440 Dose 1: Moderate Renal Impairment, GBT440 Dose 1: Normal Renal function, GBT440 Dose 1: Severe Renal Impairment |
Primary outcome
Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Time frame: 28 days max
Maximum observed plasma concentration
Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Time frame: 28 days max
AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Time frame: 28 days max
T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Time frame: 28 days max
1 secondary outcome
Number of subjects with treatment-related Adverse events
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 22 Feb 2018.
- 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.
Carla Washington study director
Global Blood Therapeutics
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 Renal Impairment, run by Global Blood Therapeutics 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 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 22 Feb 2018. 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?
Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function (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 22 Feb 2018.