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| ID | Type | Description | Link |
|---|---|---|---|
| C5351003 | Other Identifier | Alias Study Number | |
| 2022-003108-34 | EudraCT Number |
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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.
This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | open-label GBT021601 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBT021601 | Drug | Single oral dose of 200 mg GBT021601, containing ~74 kBq (~2 µCi) of [14C]-GBT021601 |
|
| Measure | Description | Time Frame |
|---|---|---|
| GBT021601 Concentration in Whole Blood and Plasma at Predose | Predose (within 60 minutes prior to GBT021601 dosing) | |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose | Data reported in microgram equivalent per milliliter (mcgEq/mL). | Predose (within 60 minutes prior to 14C-GBT021601 dosing) |
| GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours | 0.25 hours post dosing on Day 1 | |
| 14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours | 0.25 hours post dosing on Day 1 | |
| GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours | 0.50 hours post dosing on Day 1 | |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours | 0.50 hours post dosing on Day 1 | |
| GBT021601 Concentration in Whole Blood and Plasma at 1 Hours | 1 hours post dosing on Day 1 | |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours | 1 hours post dosing on Day 1 | |
| GBT021601 Concentration in Whole Blood and Plasma at 2 Hours | 2 hours post dosing on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Clinic, LLC | Groningen | 9728 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42183775 | Derived | Zimmerman EI, Callegari E, Sharma R, Adenola A, Volpe J, Seetharaman K, Zhang C, Duchin K, Walker GS. A Phase 1 Microtracer Study Evaluating the Mass Balance, Excretion, and Pharmacokinetics of Osivelotor in Healthy Participants. Clin Transl Sci. 2026 Jun;19(6):e70601. doi: 10.1111/cts.70601. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 9 participants were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | GBT021601+[14C]-GBT021601 | Participants were administered a single 200 milligrams (mg) oral dose of GBT021601 containing approximately 74 kilobecquerel (kBq) (approximately 2 microcurie [mcCi]) of [14C] labelled GBT021601 on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who had received 1 dose of GBT021601.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | GBT021601 Concentration in Whole Blood and Plasma at Predose | 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. | Posted | Mean | Standard Deviation | Microgram/ milliliter (mcg/mL) | Predose (within 60 minutes prior to GBT021601 dosing) |
|
|
From Day 1 up to maximum of Day 207
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
Data for metabolite profiling was not reported for [14C]-GBT021601 in whole blood and plasma because it was planned to be collected as part of separate, pooled analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2023 | Jul 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2023 | Jul 31, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours | 2 hours post dosing on Day 1 |
| GBT021601 Concentration in Whole Blood and Plasma at 3 Hours | 3 hours post dosing on Day 1 |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours | 3 hours post dosing on Day 1 |
| GBT021601 Concentration in Whole Blood and Plasma at 4 Hours | 4 hours post dosing on Day 1 |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours | 4 hours post dosing on Day 1 |
| GBT021601 Concentration in Whole Blood and Plasma at 6 Hours | 6 hours post dosing on Day 1 |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours | 6 hours post dosing on Day 1 |
| GBT021601 Concentration in Whole Blood and Plasma at 8 Hours | 8 hours post dosing on Day 1 |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours | 8 hours post dosing on Day 1 |
| GBT021601 Concentration in Whole Blood and Plasma at 12 Hours | 12 hours post dosing on Day 1 |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours | 12 hours post dosing on Day 1 |
| GBT021601 Concentration in Whole Blood and Plasma at 24 Hours | 24 hours post dosing on Day 1 |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours | 24 hours post dosing on Day 1 |
| GBT021601 Concentration in Whole Blood and Plasma at 48 Hours | 48 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours | 48 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 72 Hours | 72 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours | 72 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 96 Hours | 96 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours | 96 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 144 Hours | 144 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours | 144 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 168 Hours | 168 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours | 168 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 312 Hours | 312 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours | 312 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 480 Hours | 480 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours | 480 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 648 Hours | 648 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours | 648 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 816 Hours | 816 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours | 816 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 984 Hours | 984 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours | 984 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours | 1320 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours | 1320 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours | 1656 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours | 1656 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours | 1992 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours | 1992 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours | 2328 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours | 2328 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours | 2664 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours | 2664 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours | 3240 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours | 3240 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours | 3576 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours | 3576 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours | 4248 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours | 4248 hours post dosing |
| GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours | 4920 hours post dosing |
| 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours | 4920 hours post dosing |
| Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Data are reported as aggregate of all scheduled time points. | Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose |
| Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Data are reported as aggregate of all scheduled time points. | Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma | Area under the plasma concentration-time curve up to 24 hours post dose. Data reported in Hour*microgram/millimeter (h*mcg/mL). | Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours |
| Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma | Area under the plasma concentration-time curve up to 24 hours postdose. Data reported in hour*microgram equivalent/milliliter (h*mcgEq/mL). | Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours |
| Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma | Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma | Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration and Kel is apparent terminal elimination rate constant. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma | Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma | Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine | Renal clearance was calculated as CLR = Ae0-inf/AUC0-inf. Where Ae indicates Cumulative amount of drug excreted and AUC0-inf indicates Area under the plasma concentration-time curve from time 0 to infinity. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma | Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma | Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma | Apparent total clearance, calculated as dose/AUC0-inf. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma | Apparent total clearance, calculated as dose/AUC0-inf. | Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours | 0-6 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours | 6-12 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours | 12-24 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours | 0-24 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours | 24 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours | 48 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours | 72 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours | 96 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours | 120 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours | 144 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours | 168 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours | 192 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours | 216 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours | 240 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours | 264 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours | 288 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours | 312 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours | 336 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours | 360 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours | 384 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours | 408 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours | 432 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours | 456 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours | 480 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours | 504 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours | 528 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours | 552 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours | 576 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours | 600 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours | 624 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours | 648 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours | 816 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours | 984 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours | 1320 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours | 1656 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours | 1992 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours | 2328 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours | 2664 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours | 3240 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours | 3576 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours | 4248 hours post dose |
| Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours | 4920 hours post dose |
| From Day 1 up to maximum of Day 57 |
| 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. | Day 1 of dosing to Day 207 |
| 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. | Day 1 of dosing to Day 207 |
| 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. | Day 1 |
| 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. | Screening (-28 Day to -2 Day, day with respect to dosing) |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose | Data reported in microgram equivalent per milliliter (mcgEq/mL). | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | Predose (within 60 minutes prior to 14C-GBT021601 dosing) |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 0.25 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 0.25 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 0.50 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 0.50 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 1 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 1 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 1 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 2 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 2 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 2 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 3 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 3 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 3 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 4 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 4 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 4 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 6 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 6 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 6 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 8 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 8 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 8 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 12 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 12 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 12 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 24 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 24 hours post dosing on Day 1 |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 24 hours post dosing on Day 1 |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 48 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 48 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 48 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 72 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 72 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 72 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 96 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 96 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 96 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 144 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 144 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 144 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 168 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 168 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 168 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 312 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 312 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 312 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 480 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 480 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 480 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 648 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 648 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 648 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 816 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 816 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 816 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 984 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 984 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 984 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 1320 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 1320 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 1656 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 1656 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 1992 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 1992 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 2328 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 2328 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 2664 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 2664 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 3240 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 3240 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 3576 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 3576 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 4248 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 4248 hours post dosing |
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| Primary | GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours | 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. | Posted | Mean | Standard Deviation | mcg/mL | 4920 hours post dosing |
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| Primary | 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours | 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. | Posted | Mean | Standard Deviation | mcgEq/mL | 4920 hours post dosing |
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| Primary | Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Data are reported as aggregate of all scheduled time points. | 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. | Posted | Mean | Standard Deviation | milligram equivalents (mgEq) | 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 |
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| Primary | Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces | Data are reported as aggregate of all scheduled time points. | 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. | Posted | Mean | Standard Deviation | Percentage of administered drug | 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 |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*mcg/mL | Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*mcgEq/mL | Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours |
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| Primary | Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*mcg/mL | 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 |
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| Primary | Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*mcgEq/mL | 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 |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*mcg/mL | 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 |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*mcgEq/mL | 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 |
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| Primary | Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 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 |
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| Primary | Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcgEq/mL | 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 |
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| Primary | Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma | 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. | Posted | Median | Full Range | Hour (h) | 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 |
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| Primary | Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma | 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. | Posted | Median | Full Range | Hour | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Hour | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Hour | 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 |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | 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 |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | 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 |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | 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 |
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| Primary | Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma | Apparent total clearance, calculated as dose/AUC0-inf. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | 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 |
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| Primary | Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma | Apparent total clearance, calculated as dose/AUC0-inf. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | 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 |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 0-6 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 6-12 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 12-24 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 0-24 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 24 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 48 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 72 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 96 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 120 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 144 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 168 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 192 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 216 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 240 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 264 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 288 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 312 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 336 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 360 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 384 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 408 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 432 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 456 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 480 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 504 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 528 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 552 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 576 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 600 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 624 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 648 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 816 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 984 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 1320 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 1656 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 1992 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 2328 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 2664 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 3240 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 3576 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 4248 hours post dose |
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| Primary | Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours | 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. | Posted | Mean | Standard Deviation | mgEq | 4920 hours post dose |
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| 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). | Safety analysis set included all participants who had received 1 dose of GBT021601. | Posted | Count of Participants | Participants | From Day 1 up to maximum of Day 57 |
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| 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. | Safety analysis set included all participants who had received 1 dose of GBT021601. | Posted | Count of Participants | Participants | Day 1 of dosing to Day 207 |
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| 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. | Safety analysis set included all participants who had received 1 dose of GBT021601. | Posted | Count of Participants | Participants | Day 1 of dosing to Day 207 |
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| 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. | Safety analysis set included all participants who had received 1 dose of GBT021601. | Posted | Count of Participants | Participants | Day 1 |
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| 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. | Safety analysis set included all participants who had received 1 dose of GBT021601. | Posted | Count of Participants | Participants | Screening (-28 Day to -2 Day, day with respect to dosing) |
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| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Animal scratch | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
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| Polymenorrhoea | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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