Sickle Cell Disease
Conditions
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.
Detailed description
This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.
Interventions
DRUGGBT021601
Single oral dose of 200 mg GBT021601, containing \ 74 kBq (\ 2 µCi) of \[14C\]-GBT021601
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours | 4920 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 | — |
| 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 3240 Hours | 3240 hours post dosing | — |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose | Predose (within 60 minutes prior to 14C-GBT021601 dosing) | Data reported in microgram equivalent per milliliter (mcgEq/mL). |
| 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 | — |
| 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 | 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 | Data are reported as aggregate of all scheduled time points. |
| Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | 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 | Data are reported as aggregate of all scheduled time points. |
| Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma | 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 up to 24 hours post dose. Data reported in Hour\*microgram/millimeter (h\*mcg/mL). |
| Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma | 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 up to 24 hours postdose. Data reported in hour\*microgram equivalent/milliliter (h\*mcgEq/mL). |
| 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 | 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 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) 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 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. |
| 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 | 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, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant. |
| Apparent Terminal Elimination Half-Life (t1/2) 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, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant. |
| Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine | 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 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. |
| Apparent Volume of Distribution at Terminal Phase (Vz/F) 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 | Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel. |
| Apparent Volume of Distribution at Terminal Phase (Vz/F) 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 volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel. |
| Apparent Total Clearance (CL/F) 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 | Apparent total clearance, calculated as dose/AUC0-inf. |
| Apparent Total Clearance (CL/F) 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 total clearance, calculated as dose/AUC0-inf. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Laboratory Values | Day 1 of dosing to Day 207 | Blood and urine samples was collected for clinical laboratory assessments. Clinical Laboratory Values included Clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin (total, direct, and indirect), blood urea nitrogen, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, phosphorus, potassium, sodium, total protein, and uric acid. Hematology: leukocytes, erythrocytes, hematocrit, Hb, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count (ie, thrombocytes), RBC count, and white blood cell count etc. Urinalysis: determination of pH and specific gravity, and presence of bilirubin, blood, glucose, ketones, nitrite, protein, leukocytes, and urobilinogen etc. Coagulation, Serology, Drug and alcohol screen and Pregnancy test. Clinical significance was judged by investigator. |
| Number of Participants With Clinically Significant Vital Signs Values | Day 1 of dosing to Day 207 | Systolic and diastolic blood pressure and pulse was recorded after the participant had rested for at least 5 minutes in the supine position. Body temperature and respiratory rate was also measured. Clinical significance was judged by investigator. |
| Number of Participants With Clinically Significant ECG Values | Day 1 | Standard 12-lead ECGs were performed after the participant had rested quietly for more than 5 minutes in a supine position utilizing an ECG machine that was equipped with computer-based interval measurements. The following measurement was recorded: the heart rate (of \<45 or \>100 beats per minute (BPM) , PR interval, QT interval, QT interval corrected using Fridericia's formula (QTcF) of \>450 msec for males and \>470 msec for females, and QRS duration. Any cardiac rhythm other than sinus rhythm that was interpreted by the Investigator was clinically significant. |
| Number of Participants With Clinically Significant Physical Examination Values | Screening (-28 Day to -2 Day, day with respect to dosing) | Physical Examination test included body weight and height. physical examination was conducted at screening. Clinical significance was judged by investigator. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 1 up to maximum of Day 57 | An Adverse event (AE) was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. TEAEs were those which occurred (or worsened) after the dose of study drug during the on-treatment period, defined as the period after the dose of study drug and through the minimum of (Study Day 57, study discontinuation). |
Countries
Netherlands
Participant flow
Recruitment details
A total of 9 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| GBT021601+[14C]-GBT021601 Participants were administered a single 200 mg oral dose of GBT021601 containing approximately 74 kBq (approximately 2 mcCi) of \[14C\] labelled GBT021601 on Day 1. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | GBT021601+[14C]-GBT021601 |
|---|---|
| Age, Continuous | 33.6 Years STANDARD_DEVIATION 7.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 4 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours
Time frame: 0.50 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours | Plasma | 2.345 mcgEq/mL | Standard Deviation 0.6467 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours | Whole Blood | 16.45 mcgEq/mL | Standard Deviation 4.348 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours
Time frame: 12 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours | Whole Blood | 32.95 mcgEq/mL | Standard Deviation 7.459 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours | Plasma | 0.5064 mcgEq/mL | Standard Deviation 0.11455 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours
Time frame: 1320 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours | Whole Blood | 7.599 mcgEq/mL | Standard Deviation 1.1109 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours | Plasma | 0.04387 mcgEq/mL | Standard Deviation 0.004128 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours
Time frame: 144 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours | Whole Blood | 28.81 mcgEq/mL | Standard Deviation 5.988 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours | Plasma | 0.1434 mcgEq/mL | Standard Deviation 0.02345 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours
Time frame: 1656 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours | Whole Blood | 5.528 mcgEq/mL | Standard Deviation 1.0078 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours | Plasma | 0.02835 mcgEq/mL | Standard Deviation 0.004387 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours
Time frame: 168 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours | Whole Blood | 27.33 mcgEq/mL | Standard Deviation 5.329 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours | Plasma | 0.1471 mcgEq/mL | Standard Deviation 0.03267 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours
Time frame: 1992 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours | Whole Blood | 3.667 mcgEq/mL | Standard Deviation 0.5431 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours | Plasma | 0.01909 mcgEq/mL | Standard Deviation 0.004378 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours
Time frame: 1 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours | Whole Blood | 27.24 mcgEq/mL | Standard Deviation 4.59 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours | Plasma | 2.913 mcgEq/mL | Standard Deviation 0.4117 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours
Time frame: 2328 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours | Whole Blood | 2.677 mcgEq/mL | Standard Deviation 0.5212 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours | Plasma | 0.013250 mcgEq/mL | Standard Deviation 0.0042927 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours
Time frame: 24 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours | Whole Blood | 33.62 mcgEq/mL | Standard Deviation 7.819 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours | Plasma | 0.3256 mcgEq/mL | Standard Deviation 0.06395 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours
Time frame: 2664 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours | Whole Blood | 2.064 mcgEq/mL | Standard Deviation 0.3699 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours | Plasma | 0.008206 mcgEq/mL | Standard Deviation 0.0031073 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours
Time frame: 2 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours | Whole Blood | 29.52 mcgEq/mL | Standard Deviation 5.586 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours | Plasma | 2.089 mcgEq/mL | Standard Deviation 0.4195 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours
Time frame: 312 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours | Whole Blood | 23.44 mcgEq/mL | Standard Deviation 3.976 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours | Plasma | 0.1274 mcgEq/mL | Standard Deviation 0.01847 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours
Time frame: 3240 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours | Whole Blood | 0.9463 mcgEq/mL | Standard Deviation 0.30792 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours | Plasma | NA mcgEq/mL | — |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours
Time frame: 3576 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours | Whole Blood | 0.6733 mcgEq/mL | Standard Deviation 0.24908 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours | Plasma | NA mcgEq/mL | — |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours
Time frame: 3 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours | Whole Blood | 29.78 mcgEq/mL | Standard Deviation 5.54 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours | Plasma | 1.502 mcgEq/mL | Standard Deviation 0.2753 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours
Time frame: 4248 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours | Whole Blood | 0.2745 mcgEq/mL | Standard Deviation 0.14637 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours | Plasma | NA mcgEq/mL | — |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours
Time frame: 480 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours | Whole Blood | 19.30 mcgEq/mL | Standard Deviation 2.743 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours | Plasma | 0.09706 mcgEq/mL | Standard Deviation 0.010952 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours
Time frame: 48 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours | Whole Blood | 33.29 mcgEq/mL | Standard Deviation 7.384 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours | Plasma | 0.2207 mcgEq/mL | Standard Deviation 0.03853 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours
Time frame: 4920 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours | Whole Blood | 0.2330 mcgEq/mL |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours | Plasma | NA mcgEq/mL |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours
Time frame: 4 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours | Whole Blood | 31.23 mcgEq/mL | Standard Deviation 6.483 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours | Plasma | 1.2243 mcgEq/mL | Standard Deviation 0.32688 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours
Time frame: 648 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours | Whole Blood | 16.32 mcgEq/mL | Standard Deviation 2.161 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours | Plasma | 0.08224 mcgEq/mL | Standard Deviation 0.007987 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours
Time frame: 6 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours | Whole Blood | 31.51 mcgEq/mL | Standard Deviation 7.104 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours | Plasma | 0.8534 mcgEq/mL | Standard Deviation 0.19276 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours
Time frame: 72 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours | Whole Blood | 31.38 mcgEq/mL | Standard Deviation 6.475 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours | Plasma | 0.1861 mcgEq/mL | Standard Deviation 0.03361 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours
Time frame: 816 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours | Whole Blood | 12.93 mcgEq/mL | Standard Deviation 1.403 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours | Plasma | 0.08084 mcgEq/mL | Standard Deviation 0.005649 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours
Time frame: 8 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours | Whole Blood | 31.53 mcgEq/mL | Standard Deviation 8.016 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours | Plasma | 0.6592 mcgEq/mL | Standard Deviation 0.13795 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours
Time frame: 96 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours | Whole Blood | 30.62 mcgEq/mL | Standard Deviation 5.839 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours | Plasma | 0.1670 mcgEq/mL | Standard Deviation 0.03204 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours
Time frame: 984 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours | Whole Blood | 11.087 mcgEq/mL | Standard Deviation 1.4815 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours | Plasma | 0.06646 mcgEq/mL | Standard Deviation 0.005689 |
Primary
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose
Data reported in microgram equivalent per milliliter (mcgEq/mL).
Time frame: Predose (within 60 minutes prior to 14C-GBT021601 dosing)
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose | Plasma | 0 mcgEq/mL | Standard Deviation 0 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose | Whole blood | 0 mcgEq/mL | Standard Deviation 0 |
Primary
14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours
Time frame: 0.25 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours | Whole Blood | 5.8206 mcgEq/mL | Standard Deviation 4.64396 |
| GBT021601+[14C]-GBT021601 | 14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours | Plasma | 0.84819 mcgEq/mL | Standard Deviation 0.595349 |
Primary
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.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma | Whole blood | 654.7 Hour | Standard Deviation 92.46 |
| GBT021601+[14C]-GBT021601 | Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 588.9 Hour | Standard Deviation 109.92 |
Primary
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.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma | Whole blood | 647.8 Hour | Standard Deviation 84.51 |
| GBT021601+[14C]-GBT021601 | Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma | Plasma | 707.1 Hour | Standard Deviation 112.32 |
Primary
Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma
Apparent total clearance, calculated as dose/AUC0-inf.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma | Whole blood | 0.006580 L/h | Geometric Coefficient of Variation 10.5 |
| GBT021601+[14C]-GBT021601 | Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 1.1258 L/h | Geometric Coefficient of Variation 8.8 |
Primary
Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma
Apparent total clearance, calculated as dose/AUC0-inf.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma | Whole blood | 0.005713 L/h | Geometric Coefficient of Variation 12.1 |
| GBT021601+[14C]-GBT021601 | Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma | Plasma | 1.338 L/h | Geometric Coefficient of Variation 10.8 |
Primary
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.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma | Whole blood | 5.972 Liter | Geometric Coefficient of Variation 15.9 |
| GBT021601+[14C]-GBT021601 | Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 906.1 Liter | Geometric Coefficient of Variation 14.4 |
Primary
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.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma | Whole blood | 5.175 Liter (L) | Geometric Coefficient of Variation 18.3 |
| GBT021601+[14C]-GBT021601 | Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma | Plasma | 1300.6 Liter (L) | Geometric Coefficient of Variation 15.5 |
Primary
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma | Whole blood | 27609.6 h*mcgEq/mL | Geometric Coefficient of Variation 18.5 |
| GBT021601+[14C]-GBT021601 | Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 165.7 h*mcgEq/mL | Geometric Coefficient of Variation 13.1 |
Primary
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma | Whole blood | 31481.7 h*mcg/mL | Geometric Coefficient of Variation 20.9 |
| GBT021601+[14C]-GBT021601 | Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma | Plasma | 130.35 h*mcg/mL | Geometric Coefficient of Variation 16.7 |
Primary
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).
Time frame: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma | Whole Blood | 741.8 h*mcgEq/mL | Geometric Coefficient of Variation 21.3 |
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 17.92 h*mcgEq/mL | Geometric Coefficient of Variation 19.2 |
Primary
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).
Time frame: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma | Whole Blood | 824.1 h*mcg/mL | Geometric Coefficient of Variation 22.3 |
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma | Plasma | 7.393 h*mcg/mL | Geometric Coefficient of Variation 20 |
Primary
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.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma | Whole blood | 30636.1 h*mcgEq/mL | Geometric Coefficient of Variation 10.5 |
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 179.1 h*mcgEq/mL | Geometric Coefficient of Variation 8.8 |
Primary
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.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma | Whole blood | 35290.5 h*mcg/mL | Geometric Coefficient of Variation 12.1 |
| GBT021601+[14C]-GBT021601 | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma | Plasma | 150.7 h*mcg/mL | Geometric Coefficient of Variation 10.8 |
Primary
Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
Data are reported as aggregate of all scheduled time points.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Urine | 95.23 milligram equivalents (mgEq) | Standard Deviation 10.153 |
| GBT021601+[14C]-GBT021601 | Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Feces | 81.38 milligram equivalents (mgEq) | Standard Deviation 12.668 |
Primary
Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
Data are reported as aggregate of all scheduled time points.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Urine | 47.24 Percentage of administered drug | Standard Deviation 5.036 |
| GBT021601+[14C]-GBT021601 | Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Feces | 40.37 Percentage of administered drug | Standard Deviation 6.284 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours
Time frame: 0-24 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours | Feces | 0.060486 mgEq | Standard Deviation 0.1389173 |
| Unknown | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours | Urine | — mgEq | — |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours
Time frame: 0-6 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours | Urine | 13.123 mgEq | Standard Deviation 4.5812 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours
Time frame: 120 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours | Urine | 30.97 mgEq | Standard Deviation 5.791 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours | Feces | 40.54 mgEq | Standard Deviation 4.6 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours
Time frame: 12-24 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours | Urine | 19.70 mgEq | Standard Deviation 4.021 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours
Time frame: 1320 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours | Urine | 83.07 mgEq | Standard Deviation 9.068 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours | Feces | 72.95 mgEq | Standard Deviation 12.135 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours
Time frame: 144 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours | Urine | 32.88 mgEq | Standard Deviation 6.151 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours | Feces | 39.51 mgEq | Standard Deviation 8.832 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours
Time frame: 1656 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours | Urine | 89.48 mgEq | Standard Deviation 9.168 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours | Feces | 76.42 mgEq | Standard Deviation 13.642 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours
Time frame: 168 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours | Urine | 34.82 mgEq | Standard Deviation 6.438 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours | Feces | 40.87 mgEq | Standard Deviation 7.673 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours
Time frame: 192 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours | Urine | 36.72 mgEq | Standard Deviation 6.695 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours | Feces | 44.39 mgEq | Standard Deviation 5.139 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours
Time frame: 1992 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours | Urine | 93.46 mgEq | Standard Deviation 9.065 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours | Feces | 79.01 mgEq | Standard Deviation 14.557 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours
Time frame: 216 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours | Urine | 38.48 mgEq | Standard Deviation 6.926 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours | Feces | 43.09 mgEq | Standard Deviation 9.219 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours
Time frame: 2328 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here, Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where Number Analyzed signifies number of participants evaluable for specified row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours | Urine | 92.85 mgEq | Standard Deviation 7.592 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours | Feces | 84.14 mgEq | Standard Deviation 15.744 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours
Time frame: 240 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours | Urine | 40.22 mgEq | Standard Deviation 7.197 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours | Feces | 43.54 mgEq | Standard Deviation 8.212 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours
Time frame: 24 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours | Urine | 23.19 mgEq | Standard Deviation 4.305 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours | Feces | 24.25 mgEq | Standard Deviation 9.726 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours
Time frame: 264 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours | Urine | 41.99 mgEq | Standard Deviation 7.402 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours | Feces | 45.31 mgEq | Standard Deviation 8.482 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours
Time frame: 2664 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours | Urine | 100.08 mgEq | Standard Deviation 12.033 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours | Feces | 59.86 mgEq | Standard Deviation 0.613 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours
Time frame: 288 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours | Urine | 43.65 mgEq | Standard Deviation 7.589 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours | Feces | 44.72 mgEq | Standard Deviation 7.324 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours
Time frame: 312 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours | Urine | 45.06 mgEq | Standard Deviation 7.759 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours | Feces | 46.29 mgEq | Standard Deviation 9.018 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours
Time frame: 3240 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours | Urine | 98.36 mgEq | Standard Deviation 10.969 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours | Feces | 69.27 mgEq | Standard Deviation 13.344 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours
Time frame: 336 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours | Urine | 46.50 mgEq | Standard Deviation 7.899 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours | Feces | 50.24 mgEq | Standard Deviation 5.88 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours
Time frame: 3576 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here, Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours | Urine | 98.96 mgEq | Standard Deviation 11.161 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours | Feces | 69.62 mgEq | Standard Deviation 13.175 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours
Time frame: 360 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours | Urine | 47.92 mgEq | Standard Deviation 8.085 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours | Feces | 48.56 mgEq | Standard Deviation 8.315 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours
Time frame: 384 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours | Urine | 49.41 mgEq | Standard Deviation 8.242 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours | Feces | 52.20 mgEq | Standard Deviation 6.116 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours
Time frame: 408 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours | Urine | 50.87 mgEq | Standard Deviation 8.418 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours | Feces | 49.97 mgEq | Standard Deviation 9.261 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours
Time frame: 4248 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here, Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where Number Analyzed signifies number of participants evaluable for specified row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours | Urine | 93.30 mgEq | Standard Deviation 3.569 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours | Feces | 85.10 mgEq | — |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours
Time frame: 432 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours | Urine | 52.24 mgEq | Standard Deviation 8.469 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours | Feces | 50.84 mgEq | Standard Deviation 9.215 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours
Time frame: 456 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours | Urine | 53.59 mgEq | Standard Deviation 8.564 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours | Feces | 53.99 mgEq | Standard Deviation 6.398 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours
Time frame: 480 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours | Urine | 54.81 mgEq | Standard Deviation 8.616 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours | Feces | 52.89 mgEq | Standard Deviation 9.678 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours
Time frame: 48 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours | Urine | 25.50 mgEq | Standard Deviation 4.727 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours | Feces | 33.17 mgEq | Standard Deviation 7.021 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours
Time frame: 4920 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours | Urine | 96.31 mgEq |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours | Feces | 63.87 mgEq |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours
Time frame: 504 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours | Urine | 56.00 mgEq | Standard Deviation 8.649 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours | Feces | 53.22 mgEq | Standard Deviation 9.709 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours
Time frame: 528 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours | Urine | 57.15 mgEq | Standard Deviation 8.734 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours | Feces | 56.23 mgEq | Standard Deviation 6.834 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours
Time frame: 552 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours | Urine | 58.19 mgEq | Standard Deviation 8.845 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours | Feces | 55.14 mgEq | Standard Deviation 9.75 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours
Time frame: 576 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours | Urine | 59.25 mgEq | Standard Deviation 9.013 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours | Feces | 55.39 mgEq | Standard Deviation 9.766 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours
Time frame: 600 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours | Urine | 60.20 mgEq | Standard Deviation 9.159 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours | Feces | 58.26 mgEq | Standard Deviation 7.116 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours
Time frame: 6-12 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours | Urine | 16.611 mgEq | Standard Deviation 4.2333 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours
Time frame: 624 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours | Feces | 57.17 mgEq | Standard Deviation 9.867 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours | Urine | 61.13 mgEq | Standard Deviation 9.23 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours
Time frame: 648 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. ere Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours | Urine | 62.18 mgEq | Standard Deviation 9.313 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours | Feces | 59.51 mgEq | Standard Deviation 8.648 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours
Time frame: 72 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours | Urine | 27.55 mgEq | Standard Deviation 5.112 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours | Feces | 35.06 mgEq | Standard Deviation 8.909 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours
Time frame: 816 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours | Urine | 67.24 mgEq | Standard Deviation 8.848 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours | Feces | 62.99 mgEq | Standard Deviation 11.632 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours
Time frame: 96 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours | Urine | 29.35 mgEq | Standard Deviation 5.504 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours | Feces | 37.31 mgEq | Standard Deviation 8.103 |
Primary
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours
Time frame: 984 hours post dose
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours | Urine | 74.37 mgEq | Standard Deviation 9.568 |
| GBT021601+[14C]-GBT021601 | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours | Feces | 67.30 mgEq | Standard Deviation 11.537 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours
Time frame: 0.25 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours | Whole blood | 6.368 mcg/mL | Standard Deviation 5.4178 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours | Plasma | 0.46267 mcg/mL | Standard Deviation 0.373675 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours
Time frame: 0.50 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours | Whole Blood | 17.33 mcg/mL | Standard Deviation 4.122 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours | Plasma | 1.2338 mcg/mL | Standard Deviation 0.37097 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 12 Hours
Time frame: 12 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 12 Hours | Whole Blood | 36.49 mcg/mL | Standard Deviation 10.844 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 12 Hours | Plasma | 0.1986 mcg/mL | Standard Deviation 0.05917 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours
Time frame: 1320 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours | Whole Blood | 8.772 mcg/mL | Standard Deviation 1.1434 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours | Plasma | 0.03829 mcg/mL | Standard Deviation 0.003602 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 144 Hours
Time frame: 144 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 144 Hours | Whole Blood | 32.48 mcg/mL | Standard Deviation 7.257 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 144 Hours | Plasma | 0.11038 mcg/mL | Standard Deviation 0.016657 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours
Time frame: 1656 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours | Whole Blood | 6.253 mcg/mL | Standard Deviation 0.9576 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours | Plasma | 0.02809 mcg/mL | Standard Deviation 0.005965 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 168 Hours
Time frame: 168 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 168 Hours | Whole Blood | 32.91 mcg/mL | Standard Deviation 7.603 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 168 Hours | Plasma | 0.12189 mcg/mL | Standard Deviation 0.020679 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours
Time frame: 1992 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours | Whole Blood | 4.283 mcg/mL | Standard Deviation 0.731 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours | Plasma | 0.01881 mcg/mL | Standard Deviation 0.003921 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 1 Hours
Time frame: 1 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1 Hours | Whole Blood | 29.37 mcg/mL | Standard Deviation 4.52 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 1 Hours | Plasma | 1.433 mcg/mL | Standard Deviation 0.1997 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours
Time frame: 2328 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours | Whole Blood | 2.997 mcg/mL | Standard Deviation 0.6994 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours | Plasma | 0.01407 mcg/mL | Standard Deviation 0.007193 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 24 Hours
Time frame: 24 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 24 Hours | Whole Blood | 37.53 mcg/mL | Standard Deviation 8.855 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 24 Hours | Plasma | 0.1479 mcg/mL | Standard Deviation 0.03685 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours
Time frame: 2664 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours | Whole Blood | 2.290 mcg/mL | Standard Deviation 0.4786 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours | Plasma | NA mcg/mL | — |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 2 Hours
Time frame: 2 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 2 Hours | Whole Blood | 31.92 mcg/mL | Standard Deviation 6.544 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 2 Hours | Plasma | 0.9228 mcg/mL | Standard Deviation 0.21798 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 312 Hours
Time frame: 312 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 312 Hours | Whole Blood | 26.59 mcg/mL | Standard Deviation 5.353 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 312 Hours | Plasma | 0.11109 mcg/mL | Standard Deviation 0.024207 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours
Time frame: 3240 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours | Whole Blood | 1.1523 mcg/mL | Standard Deviation 0.38725 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours | Plasma | NA mcg/mL | — |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours
Time frame: 3576 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours | Whole Blood | 0.6097 mcg/mL | Standard Deviation 0.52801 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours | Plasma | NA mcg/mL | — |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 3 Hours
Time frame: 3 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 3 Hours | Whole Blood | 31.92 mcg/mL | Standard Deviation 6.544 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 3 Hours | Plasma | 0.5974 mcg/mL | Standard Deviation 0.13629 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours
Time frame: 4248 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours | Whole Blood | NA mcg/mL |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours | Plasma | NA mcg/mL |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 480 Hours
Time frame: 480 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 480 Hours | Whole Blood | 22.38 mcg/mL | Standard Deviation 3.991 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 480 Hours | Plasma | 0.08271 mcg/mL | Standard Deviation 0.014586 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 48 Hours
Time frame: 48 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 48 Hours | Whole Blood | 37.39 mcg/mL | Standard Deviation 9.904 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 48 Hours | Plasma | 0.1402 mcg/mL | Standard Deviation 0.02718 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours
Time frame: 4920 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours | Whole Blood | NA mcg/mL |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours | Plasma | NA mcg/mL |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 4 Hours
Time frame: 4 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 4 Hours | Whole Blood | 34.96 mcg/mL | Standard Deviation 6.738 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 4 Hours | Plasma | 0.4539 mcg/mL | Standard Deviation 0.1482 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 648 Hours
Time frame: 648 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 648 Hours | Whole Blood | 18.71 mcg/mL | Standard Deviation 3.597 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 648 Hours | Plasma | 0.07343 mcg/mL | Standard Deviation 0.011345 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 6 Hours
Time frame: 6 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 6 Hours | Whole Blood | 34.84 mcg/mL | Standard Deviation 7.996 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 6 Hours | Plasma | 0.3013 mcg/mL | Standard Deviation 0.07405 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 72 Hours
Time frame: 72 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 72 Hours | Whole Blood | 35.41 mcg/mL | Standard Deviation 7.642 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 72 Hours | Plasma | 0.1377 mcg/mL | Standard Deviation 0.03011 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 816 Hours
Time frame: 816 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 816 Hours | Whole Blood | 15.20 mcg/mL | Standard Deviation 1.553 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 816 Hours | Plasma | 0.06894 mcg/mL | Standard Deviation 0.011486 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 8 Hours
Time frame: 8 hours post dosing on Day 1
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 8 Hours | Whole Blood | 36.00 mcg/mL | Standard Deviation 8.979 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 8 Hours | Plasma | 0.2267 mcg/mL | Standard Deviation 0.0621 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 96 Hours
Time frame: 96 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 96 Hours | Whole Blood | 34.67 mcg/mL | Standard Deviation 7.339 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 96 Hours | Plasma | 0.12923 mcg/mL | Standard Deviation 0.026617 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at 984 Hours
Time frame: 984 hours post dosing
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 984 Hours | Whole Blood | 12.60 mcg/mL | Standard Deviation 1.715 |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at 984 Hours | Plasma | 0.05919 mcg/mL | Standard Deviation 0.006786 |
Primary
GBT021601 Concentration in Whole Blood and Plasma at Predose
Time frame: Predose (within 60 minutes prior to GBT021601 dosing)
Population: Pharmacokinetic (PK) analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at Predose | Whole blood | NA Microgram/ milliliter (mcg/mL) |
| GBT021601+[14C]-GBT021601 | GBT021601 Concentration in Whole Blood and Plasma at Predose | Plasma | NA Microgram/ milliliter (mcg/mL) |
Primary
Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma | Whole blood | 34.05 mcgEq/mL | Geometric Coefficient of Variation 20.8 |
| GBT021601+[14C]-GBT021601 | Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 2.950 mcgEq/mL | Geometric Coefficient of Variation 12.5 |
Primary
Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma | Whole blood | 40.06 mcg/mL | Geometric Coefficient of Variation 27.1 |
| GBT021601+[14C]-GBT021601 | Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma | Plasma | 1.468 mcg/mL | Geometric Coefficient of Variation 14 |
Primary
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.
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine | 0.2755 Liter/hour (L/h) | Geometric Coefficient of Variation 12.6 |
Primary
Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma | Plasma | 1.000 Hour |
| GBT021601+[14C]-GBT021601 | Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma | Whole blood | 24.000 Hour |
Primary
Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma
Time frame: 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
Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GBT021601+[14C]-GBT021601 | Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma | Whole blood | 24.000 Hour (h) |
| GBT021601+[14C]-GBT021601 | Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma | Plasma | 1.000 Hour (h) |
Secondary
Number of Participants With Clinically Significant ECG Values
Standard 12-lead ECGs were performed after the participant had rested quietly for more than 5 minutes in a supine position utilizing an ECG machine that was equipped with computer-based interval measurements. The following measurement was recorded: the heart rate (of \<45 or \>100 beats per minute (BPM) , PR interval, QT interval, QT interval corrected using Fridericia's formula (QTcF) of \>450 msec for males and \>470 msec for females, and QRS duration. Any cardiac rhythm other than sinus rhythm that was interpreted by the Investigator was clinically significant.
Time frame: Day 1
Population: Safety analysis set included all participants who had received 1 dose of GBT021601.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBT021601+[14C]-GBT021601 | Number of Participants With Clinically Significant ECG Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Values
Blood and urine samples was collected for clinical laboratory assessments. Clinical Laboratory Values included Clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin (total, direct, and indirect), blood urea nitrogen, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, phosphorus, potassium, sodium, total protein, and uric acid. Hematology: leukocytes, erythrocytes, hematocrit, Hb, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count (ie, thrombocytes), RBC count, and white blood cell count etc. Urinalysis: determination of pH and specific gravity, and presence of bilirubin, blood, glucose, ketones, nitrite, protein, leukocytes, and urobilinogen etc. Coagulation, Serology, Drug and alcohol screen and Pregnancy test. Clinical significance was judged by investigator.
Time frame: Day 1 of dosing to Day 207
Population: Safety analysis set included all participants who had received 1 dose of GBT021601.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBT021601+[14C]-GBT021601 | Number of Participants With Clinically Significant Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Physical Examination Values
Physical Examination test included body weight and height. physical examination was conducted at screening. Clinical significance was judged by investigator.
Time frame: Screening (-28 Day to -2 Day, day with respect to dosing)
Population: Safety analysis set included all participants who had received 1 dose of GBT021601.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBT021601+[14C]-GBT021601 | Number of Participants With Clinically Significant Physical Examination Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Signs Values
Systolic and diastolic blood pressure and pulse was recorded after the participant had rested for at least 5 minutes in the supine position. Body temperature and respiratory rate was also measured. Clinical significance was judged by investigator.
Time frame: Day 1 of dosing to Day 207
Population: Safety analysis set included all participants who had received 1 dose of GBT021601.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBT021601+[14C]-GBT021601 | Number of Participants With Clinically Significant Vital Signs Values | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse event (AE) was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. TEAEs were those which occurred (or worsened) after the dose of study drug during the on-treatment period, defined as the period after the dose of study drug and through the minimum of (Study Day 57, study discontinuation).
Time frame: From Day 1 up to maximum of Day 57
Population: Safety analysis set included all participants who had received 1 dose of GBT021601.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GBT021601+[14C]-GBT021601 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 4 Participants |