A GBT021601 ADME Microtracer Study in Healthy Volunteers

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05718687
• Other study ID #: GBT021601-013
• Secondary ID: C5351003
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening.
• Body weight = 50 kg at screening
• Females must be nonlactating and nonpregnant (as confirmed by a negative serum pregnancy test at screening and admission for all females), or of nonchildbearing potential (ie, either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [defined as at least 12 months no menses, and confirmed by a follicle-stimulating hormone test, at screening]).
• Creatinine clearance (glomerular filtration rate) as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula: =90 mL/min, at screening.

Exclusion Criteria:

• History or presence of conditions which, in the opinion of the Investigator, are known to interfere with the ADME of drugs, such as previous surgery on the gastrointestinal tract (including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas). Participants who have a history of appendectomy are eligible for enrollment.
• History of chronic constipation, or recent complaints of an irregular defecation
• Significant and/or acute illness at screening or within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
• Known personal or family history of congenital long QT syndrome or known family history of sudden death.
• Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year prior to screening.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
Netherlands	ICON Early Phase Clinic, LLC	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the whole blood and plasma concentrations of 14C-GBT021601 total radioactivity.	Total radioactivity pharmacokinetics concentration over time profiles.	Day 1 to Day 206, maximum
Primary	To assess the mass balance by determining 14C-GBT021601 total radioactivity excreted in urine and feces.	Excretion of total radioactivity in urine and feces.	Day 1 to Day 206, maximum
Primary	To determine the pharmacokinetics of GBT021601 in whole blood, plasma, and urine.	GBT021601 pharmacokinetics concentration over time profiles in whole blood and plasma. Amount of GBT021601 excreted in urine.	Day 1 to Day 206, maximum
Secondary	To assess the safety and tolerability of GBT021601 administration in healthy participants.	Number of participants with adverse events	Baseline to Day 206, maximum
Secondary	To characterize and identify metabolites of 14C-GBT021601 in whole blood, plasma, urine, and feces.	Identification of metabolites in whole blood, plasma, urine, and feces.	Day 1 to Day 206, maximum

External Links

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