CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
GBT021601drug
Likely dose
200 mg orally, single doseAI-extracted
Key inclusion· 4
  • ✓BMI 18.0–27.0 kg/m² at screening
  • ✓Body weight ≥50 kg at screening
  • ✓Females must be nonpregnant, nonlactating, or of nonchildbearing potential
  • ✓Creatinine clearance (GFR) ≥90 mL/min by CKD-EPI at screening
Key exclusion· 5
  • ✕History or presence of conditions affecting drug ADME (e.g., GI surgery excluding appendectomy)
  • ✕History of chronic constipation or recent irregular defecation
  • ✕Significant or acute illness within 5 days prior to drug administration that may impact safety
  • ✕Known personal or family history of congenital long QT syndrome or family history of sudden death

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05718687
NCT05718687Phase 1Completed
CompareCT.gov

A PHASE 1 STUDY TO ASSESS THE MASS BALANCE, EXCRETION, AND PHARMACOKINETICS OF [14C]-GBT021601, AN ORAL HEMOGLOBIN SPOLYMERIZATION INHIBITOR, IN HEALTHY PARTICIPANTS

Pfizer·interventional·Posted Feb 8, 2023·Updated Jan 8, 2025

In Brief

A Phase 1 clinical trial evaluating GBT021601 for Sickle Cell Disease. Completed, enrolled 9 participants across 1 site.

Detailed Summary

An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedFeb 8, 2023
Enrollment StartDec 22, 2022
Primary CompletionAug 10, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.4 years ago

Interventions

GBT021601drug

Single oral dose of 200 mg GBT021601, containing \~74 kBq (\~2 µCi) of \[14C\]-GBT021601