Renal ImpairmentPhase 1NCT05878704
Study of GBT021601 in Participants With Renal Impairment
A Phase 1 study testing GBT021601 in people with Renal Impairment, run by Pfizer at 4 sites in United States.
Trial summary
Renal Impairment study of GBT021601. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Impairment
- What is being tested?
- GBT021601
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jun 2023to 29 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, ≥ 18 years of age at the time of Screening.
- Have liver (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin [direct and indirect]) and renal function tests, Hb, and hematocrit values within normal limits or are not clinically significant at Screening and Day -1 (Cohort 2 only).
- Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration.
Who cannot join
- Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests unrelated to their medical condition related to renal impairment, that might confound the results of the study or pose an additional risk in administering study drug to the participant.
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at the time of study drug administration), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease unrelated to renal impairment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Orange County Research Center
Lake Forest, California, 92630
Advanced Pharma CR, LLC
Miami, Florida, 33147
Nucleus Network
Saint Paul, Minnesota, 55114
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment
Renal Impairment study of GBT021601.
Read the detailed description
This is a Phase 1, two-part, non-randomized, open-label, parallel group study to evaluate the PK, safety, and tolerability of GBT021601 following a single dose administration in adult participants with RI.
- Conditions
- Renal Impairment
- Being tested
- GBT021601
- Keywords
- End stage renal disease, Sickle Cell Disease
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBT021601Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | GBT021601 Receives: Drug: GBT021601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of GBT021601 in whole blood and plasma
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)
Measured: Up to 112 Days
Single-dose PK parameters
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment
Measured: Up to 112 Days
Secondary outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
To evaluate the safety and tolerability of single dose GBT021601 in participants with renal impairment
Measured: Up to 112 Days
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose
Measured: Up to 112 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start29 Jun 2023
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Why it stopped: Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT05878704
- Sponsor's protocol ID
- GBT021601-014
- Other IDs
- C5351007
- Status last verified
- Oct 2024
- First submitted
- 19 May 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment
- ClinicalTrials.gov ID
- NCT05878704
- Acronym / sponsor ID
- GBT021601-014
- Conditions
- Renal Impairment
- Keywords
- End stage renal disease, Sickle Cell Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 26 May 2023 (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.
Renal Impairment study of GBT021601.
Detailed description
This is a Phase 1, two-part, non-randomized, open-label, parallel group study to evaluate the PK, safety, and tolerability of GBT021601 following a single dose administration in adult participants with RI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: GBT021601GBT021601 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, ≥ 18 years of age at the time of Screening.
- Have liver (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin [direct and indirect]) and renal function tests, Hb, and hematocrit values within normal limits or are not clinically significant at Screening and Day -1 (Cohort 2 only).
- Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration.
Key exclusion criteria (2 listed)
- Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests unrelated to their medical condition related to renal impairment, that might confound the results of the study or pose an additional risk in administering study drug to the participant.
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at the time of study drug administration), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease unrelated to renal impairment.
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 |
|---|---|---|
| GBT021601Oral | Drug | Treatment |
Primary outcome
Concentration of GBT021601 in whole blood and plasma
Time frame: Up to 112 Days
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)
Single-dose PK parameters
Time frame: Up to 112 Days
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment
2 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
Time frame: Up to 112 Days
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
Time frame: Up to 112 Days
Results and safety
The study was stopped early (reason given: Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
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 GBT021601 in people with Renal Impairment, run by Pfizer 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Oct 2024. 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 was stopped early (reason given: Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.). Results are not available in the source record.
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?
Concentration of GBT021601 in whole blood and plasma (time frame: Up to 112 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 15 Oct 2024.