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NCT05878704 | Recruiting | Renal Impairment

Study of GBT021601 in Participants With Renal Impairment
Sponsor:

Pfizer

Brief Summary:

Renal Impairment study of GBT021601.

Condition or disease

Renal Impairment

Intervention/treatment

GBT021601

Phase

Phase 1

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 Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : June 29, 2023
Estimated Primary Completion Date : October 4, 2024
Estimated Study Completion Date : October 4, 2024
Arm Intervention/treatment

Experimental: Treatment

GBT021601

Drug: GBT021601
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.
Study of GBT021601 in Participants With Renal Impairment

Location Details

Please Choose a site

Study of GBT021601 in Participants With Renal Impairment

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, California

Orange County Research Center

Lake Forest, California, United States, 92630

Recruiting

United States, California

Orange County Research Center

I felt it, California, United States, 92780

Recruiting

United States, Florida

Advanced Pharma CR, LLC

Miami, florida, United States, 33147

Recruiting

United States, Minnesota

Nucleus Network

St.Paul, Minnesota, United States, 55114