A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants
NCT05036512 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 129
Last updated 2023-07-25
Summary
This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy participants.
Conditions
Interventions
- DRUG
-
GBT021601
Administered orally with water as a single dose in the morning.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-12-09
- Primary Completion
- 2022-11-02
- Completion
- 2023-02-07
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
More Related Trials
-
Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
NCT04255875 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
NCT06924970 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease
NCT02285088 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
NCT05904093 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
NCT03132324 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Oral GSK4172239D Compared With Placebo in Sickle Cell Disease Participants Aged 18 to 50 Years
NCT05660265 ·Status: TERMINATED ·Phase: PHASE1
-
The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
NCT06975865 ·Status: RECRUITING ·Phase: PHASE3
-
A Study Evaluating the Safety and Efficacy of LentiGlobin BB305 Drug Product in β-Thalassemia Major (Also Referred to as Transfusion-dependent β-Thalassemia [TDT]) and Sickle Cell Disease
NCT02151526 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD)
NCT01783691 ·Status: COMPLETED ·Phase: PHASE1
-
Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.
NCT05145062 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)
NCT03285178 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
NCT04610866 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Evaluate Efficacy and Safety of S303 Treated Red Blood Cells (RBCs)in Subjects With Thalassemia Major Requiring Chronic RBC Transfusion
NCT01740531 ·Status: COMPLETED ·Phase: PHASE3
-
A Dose-Finding Study of AG-348 in Sickle Cell Disease
NCT04000165 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects
NCT02567695 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
NCT05861453 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease
NCT04536792 ·Status: COMPLETED ·Phase: PHASE1
-
Study of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)
NCT07012109 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
YOLT-204 in Patients With Hemoglobinopathies
NCT07190001 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients
NCT05791591 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
NCT00586651 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply
NCT04182100 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
NCT05348915 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
NCT02497924 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
NCT02961218 ·Status: COMPLETED ·Phase: PHASE2