NCT05878704

Brief Summary

Renal Impairment study of GBT021601.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 29, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

May 19, 2023

Last Update Submit

October 11, 2024

Conditions

Renal Impairment

Keywords

End stage renal diseaseSickle Cell Disease

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    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

    Up to 112 Days

  • Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs

    Up to 112 Days

Other Outcomes (6)

  • Single-dose PK parameters for GBT021601 in RBC

    Up to 112 Days

  • Amount of GBT021601 excreted in urine

    Up to 112 Days

  • Descriptive analysis of eGFR versus PK exposure parameters

    Up to 112 Days

  • +3 more other outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

GBT021601

Drug: GBT021601

Interventions

GBT021601DRUG

Oral

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Related Links

MeSH Terms

Conditions

Renal InsufficiencyKidney Failure, ChronicAnemia, Sickle Cell

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 26, 2023

Study Start

June 29, 2023

Primary Completion

July 29, 2024

Study Completion

July 29, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(4)