A GBT021601 ADME Microtracer Study in Healthy Volunteers

NCT05718687 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: GBT021601-013C53510032022-003108-34
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (121)

• GBT021601 Concentration in Whole Blood and Plasma at Predose

  Predose (within 60 minutes prior to GBT021601 dosing)

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

  Data reported in microgram equivalent per milliliter (mcgEq/mL).

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

• GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours

  0.25 hours post dosing on Day 1

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

  0.25 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours

  0.50 hours post dosing on Day 1

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

  0.50 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 1 Hours

  1 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours

  1 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 2 Hours

  2 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours

  2 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 3 Hours

  3 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours

  3 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 4 Hours

  4 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours

  4 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 6 Hours

  6 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours

  6 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 8 Hours

  8 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours

  8 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 12 Hours

  12 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours

  12 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 24 Hours

  24 hours post dosing on Day 1

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours

  24 hours post dosing on Day 1

• GBT021601 Concentration in Whole Blood and Plasma at 48 Hours

  48 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours

  48 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 72 Hours

  72 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours

  72 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 96 Hours

  96 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours

  96 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 144 Hours

  144 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours

  144 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 168 Hours

  168 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours

  168 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 312 Hours

  312 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours

  312 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 480 Hours

  480 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours

  480 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 648 Hours

  648 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours

  648 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 816 Hours

  816 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours

  816 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 984 Hours

  984 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours

  984 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours

  1320 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours

  1320 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours

  1656 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours

  1656 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours

  1992 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours

  1992 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours

  2328 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours

  2328 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours

  2664 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours

  2664 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours

  3240 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours

  3240 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours

  3576 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours

  3576 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours

  4248 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours

  4248 hours post dosing

• GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours

  4920 hours post dosing

• 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours

  4920 hours post dosing

• Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces

  Data are reported as aggregate of all scheduled time points.

  Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose

• Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces

  Data are reported as aggregate of all scheduled time points.

  Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma

  Area under the plasma concentration-time curve up to 24 hours post dose. Data reported in Hour\*microgram/millimeter (h\*mcg/mL).

  Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours

• Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma

  Area under the plasma concentration-time curve up to 24 hours postdose. Data reported in hour\*microgram equivalent/milliliter (h\*mcgEq/mL).

  Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours

• Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma

  Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma

  Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration and Kel is apparent terminal elimination rate constant.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma

  Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma

  Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine

  Renal clearance was calculated as CLR = Ae0-inf/AUC0-inf. Where Ae indicates Cumulative amount of drug excreted and AUC0-inf indicates Area under the plasma concentration-time curve from time 0 to infinity.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma

  Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma

  Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma

  Apparent total clearance, calculated as dose/AUC0-inf.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma

  Apparent total clearance, calculated as dose/AUC0-inf.

  Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours

  0-6 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours

  6-12 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours

  12-24 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours

  0-24 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours

  24 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours

  48 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours

  72 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours

  96 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours

  120 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours

  144 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours

  168 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours

  192 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours

  216 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours

  240 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours

  264 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours

  288 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours

  312 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours

  336 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours

  360 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours

  384 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours

  408 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours

  432 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours

  456 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours

  480 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours

  504 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours

  528 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours

  552 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours

  576 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours

  600 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours

  624 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours

  648 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours

  816 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours

  984 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours

  1320 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours

  1656 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours

  1992 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours

  2328 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours

  2664 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours

  3240 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours

  3576 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours

  4248 hours post dose

• Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours

  4920 hours post dose

Secondary Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From Day 1 up to maximum of Day 57

• Number of Participants With Clinically Significant Laboratory Values

  Day 1 of dosing to Day 207

• Number of Participants With Clinically Significant Vital Signs Values

  Day 1 of dosing to Day 207

• Number of Participants With Clinically Significant ECG Values

  Day 1

• Number of Participants With Clinically Significant Physical Examination Values

  Screening (-28 Day to -2 Day, day with respect to dosing)

Study Arms (1)

Treatment

EXPERIMENTAL

open-label GBT021601

Drug: GBT021601

Interventions

GBT021601 DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

ICON Early Phase Clinic, LLC

Groningen, 9728, Netherlands

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Data for metabolite profiling was not reported for \[14C\]-GBT021601 in whole blood and plasma because it was planned to be collected as part of separate, pooled analysis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: December 22, 2022
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)