CompletedPhase 1

A GBT021601 ADME Microtracer Study in Healthy Volunteers

Netherlands9 participantsStarted 2022-12-22

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 i…

What they're measuring

GBT021601 Concentration in Whole Blood and Plasma at Predose

Timeframe: Predose (within 60 minutes prior to GBT021601 dosing)

14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose

Timeframe: Predose (within 60 minutes prior to 14C-GBT021601 dosing)

GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours

Timeframe: 0.25 hours post dosing on Day 1

14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours

Timeframe: 0.25 hours post dosing on Day 1

GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours

Timeframe: 0.50 hours post dosing on Day 1

14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours

Timeframe: 0.50 hours post dosing on Day 1

GBT021601 Concentration in Whole Blood and Plasma at 1 Hours

Timeframe: 1 hours post dosing on Day 1

Trial details

NCT IDNCT05718687

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-10

Results submitted2024-07-31

View on ClinicalTrials.gov More Sickle Cell Disease trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

GBT021601 Concentration in Whole Blood and Plasma at Predose

Timeframe: Predose (within 60 minutes prior to GBT021601 dosing)

14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose

Timeframe: Predose (within 60 minutes prior to 14C-GBT021601 dosing)

GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours

Timeframe: 0.25 hours post dosing on Day 1

14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours

Timeframe: 0.25 hours post dosing on Day 1

GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours

Timeframe: 0.50 hours post dosing on Day 1

14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours

Timeframe: 0.50 hours post dosing on Day 1

GBT021601 Concentration in Whole Blood and Plasma at 1 Hours

Timeframe: 1 hours post dosing on Day 1