Trial Outcomes & Findings for A GBT021601 ADME Microtracer Study in Healthy Volunteers (NCT NCT05718687)

NCT ID: NCT05718687

Last Updated: 2025-01-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: Predose (within 60 minutes prior to GBT021601 dosing)
• Results posted on: 2025-01-08

Participant Flow

A total of 9 participants were enrolled in this study.

Participant milestones

Measure	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.
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

A GBT021601 ADME Microtracer Study in Healthy Volunteers

Baseline characteristics by cohort

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Age, Continuous	33.6 Years STANDARD_DEVIATION 7.42 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

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

Population: Pharmacokinetic (PK) analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at Predose Whole blood	NA Microgram/ milliliter (mcg/mL) Standard Deviation NA Mean and SD were not estimated as data was below the lower limit of quantification (LLOQ),
GBT021601 Concentration in Whole Blood and Plasma at Predose Plasma	NA Microgram/ milliliter (mcg/mL) Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose Whole blood	0 mcgEq/mL Standard Deviation 0
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose Plasma	0 mcgEq/mL Standard Deviation 0

PRIMARY outcome

Timeframe: 0.25 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours Whole blood	6.368 mcg/mL Standard Deviation 5.4178
GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours Plasma	0.46267 mcg/mL Standard Deviation 0.373675

PRIMARY outcome

Timeframe: 0.25 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours Whole Blood	5.8206 mcgEq/mL Standard Deviation 4.64396
14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours Plasma	0.84819 mcgEq/mL Standard Deviation 0.595349

PRIMARY outcome

Timeframe: 0.50 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours Whole Blood	17.33 mcg/mL Standard Deviation 4.122
GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours Plasma	1.2338 mcg/mL Standard Deviation 0.37097

PRIMARY outcome

Timeframe: 0.50 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours Whole Blood	16.45 mcgEq/mL Standard Deviation 4.348
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours Plasma	2.345 mcgEq/mL Standard Deviation 0.6467

PRIMARY outcome

Timeframe: 1 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 1 Hours Whole Blood	29.37 mcg/mL Standard Deviation 4.520
GBT021601 Concentration in Whole Blood and Plasma at 1 Hours Plasma	1.433 mcg/mL Standard Deviation 0.1997

PRIMARY outcome

Timeframe: 1 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours Whole Blood	27.24 mcgEq/mL Standard Deviation 4.590
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours Plasma	2.913 mcgEq/mL Standard Deviation 0.4117

PRIMARY outcome

Timeframe: 2 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 2 Hours Whole Blood	31.92 mcg/mL Standard Deviation 6.544
GBT021601 Concentration in Whole Blood and Plasma at 2 Hours Plasma	0.9228 mcg/mL Standard Deviation 0.21798

PRIMARY outcome

Timeframe: 2 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours Whole Blood	29.52 mcgEq/mL Standard Deviation 5.586
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours Plasma	2.089 mcgEq/mL Standard Deviation 0.4195

PRIMARY outcome

Timeframe: 3 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 3 Hours Plasma	0.5974 mcg/mL Standard Deviation 0.13629
GBT021601 Concentration in Whole Blood and Plasma at 3 Hours Whole Blood	31.92 mcg/mL Standard Deviation 6.544

PRIMARY outcome

Timeframe: 3 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours Whole Blood	29.78 mcgEq/mL Standard Deviation 5.540
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours Plasma	1.502 mcgEq/mL Standard Deviation 0.2753

PRIMARY outcome

Timeframe: 4 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 4 Hours Whole Blood	34.96 mcg/mL Standard Deviation 6.738
GBT021601 Concentration in Whole Blood and Plasma at 4 Hours Plasma	0.4539 mcg/mL Standard Deviation 0.14820

PRIMARY outcome

Timeframe: 4 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours Whole Blood	31.23 mcgEq/mL Standard Deviation 6.483
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours Plasma	1.2243 mcgEq/mL Standard Deviation 0.32688

PRIMARY outcome

Timeframe: 6 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 6 Hours Whole Blood	34.84 mcg/mL Standard Deviation 7.996
GBT021601 Concentration in Whole Blood and Plasma at 6 Hours Plasma	0.3013 mcg/mL Standard Deviation 0.07405

PRIMARY outcome

Timeframe: 6 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours Whole Blood	31.51 mcgEq/mL Standard Deviation 7.104
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours Plasma	0.8534 mcgEq/mL Standard Deviation 0.19276

PRIMARY outcome

Timeframe: 8 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 8 Hours Whole Blood	36.00 mcg/mL Standard Deviation 8.979
GBT021601 Concentration in Whole Blood and Plasma at 8 Hours Plasma	0.2267 mcg/mL Standard Deviation 0.06210

PRIMARY outcome

Timeframe: 8 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours Whole Blood	31.53 mcgEq/mL Standard Deviation 8.016
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours Plasma	0.6592 mcgEq/mL Standard Deviation 0.13795

PRIMARY outcome

Timeframe: 12 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 12 Hours Whole Blood	36.49 mcg/mL Standard Deviation 10.844
GBT021601 Concentration in Whole Blood and Plasma at 12 Hours Plasma	0.1986 mcg/mL Standard Deviation 0.05917

PRIMARY outcome

Timeframe: 12 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours Whole Blood	32.95 mcgEq/mL Standard Deviation 7.459
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours Plasma	0.5064 mcgEq/mL Standard Deviation 0.11455

PRIMARY outcome

Timeframe: 24 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 24 Hours Whole Blood	37.53 mcg/mL Standard Deviation 8.855
GBT021601 Concentration in Whole Blood and Plasma at 24 Hours Plasma	0.1479 mcg/mL Standard Deviation 0.03685

PRIMARY outcome

Timeframe: 24 hours post dosing on Day 1

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours Whole Blood	33.62 mcgEq/mL Standard Deviation 7.819
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours Plasma	0.3256 mcgEq/mL Standard Deviation 0.06395

PRIMARY outcome

Timeframe: 48 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 48 Hours Whole Blood	37.39 mcg/mL Standard Deviation 9.904
GBT021601 Concentration in Whole Blood and Plasma at 48 Hours Plasma	0.1402 mcg/mL Standard Deviation 0.02718

PRIMARY outcome

Timeframe: 48 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours Whole Blood	33.29 mcgEq/mL Standard Deviation 7.384
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours Plasma	0.2207 mcgEq/mL Standard Deviation 0.03853

PRIMARY outcome

Timeframe: 72 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 72 Hours Whole Blood	35.41 mcg/mL Standard Deviation 7.642
GBT021601 Concentration in Whole Blood and Plasma at 72 Hours Plasma	0.1377 mcg/mL Standard Deviation 0.03011

PRIMARY outcome

Timeframe: 72 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours Whole Blood	31.38 mcgEq/mL Standard Deviation 6.475
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours Plasma	0.1861 mcgEq/mL Standard Deviation 0.03361

PRIMARY outcome

Timeframe: 96 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 96 Hours Whole Blood	34.67 mcg/mL Standard Deviation 7.339
GBT021601 Concentration in Whole Blood and Plasma at 96 Hours Plasma	0.12923 mcg/mL Standard Deviation 0.026617

PRIMARY outcome

Timeframe: 96 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours Whole Blood	30.62 mcgEq/mL Standard Deviation 5.839
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours Plasma	0.1670 mcgEq/mL Standard Deviation 0.03204

PRIMARY outcome

Timeframe: 144 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 144 Hours Whole Blood	32.48 mcg/mL Standard Deviation 7.257
GBT021601 Concentration in Whole Blood and Plasma at 144 Hours Plasma	0.11038 mcg/mL Standard Deviation 0.016657

PRIMARY outcome

Timeframe: 144 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours Whole Blood	28.81 mcgEq/mL Standard Deviation 5.988
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours Plasma	0.1434 mcgEq/mL Standard Deviation 0.02345

PRIMARY outcome

Timeframe: 168 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 168 Hours Whole Blood	32.91 mcg/mL Standard Deviation 7.603
GBT021601 Concentration in Whole Blood and Plasma at 168 Hours Plasma	0.12189 mcg/mL Standard Deviation 0.020679

PRIMARY outcome

Timeframe: 168 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours Whole Blood	27.33 mcgEq/mL Standard Deviation 5.329
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours Plasma	0.1471 mcgEq/mL Standard Deviation 0.03267

PRIMARY outcome

Timeframe: 312 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 312 Hours Whole Blood	26.59 mcg/mL Standard Deviation 5.353
GBT021601 Concentration in Whole Blood and Plasma at 312 Hours Plasma	0.11109 mcg/mL Standard Deviation 0.024207

PRIMARY outcome

Timeframe: 312 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours Whole Blood	23.44 mcgEq/mL Standard Deviation 3.976
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours Plasma	0.1274 mcgEq/mL Standard Deviation 0.01847

PRIMARY outcome

Timeframe: 480 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 480 Hours Whole Blood	22.38 mcg/mL Standard Deviation 3.991
GBT021601 Concentration in Whole Blood and Plasma at 480 Hours Plasma	0.08271 mcg/mL Standard Deviation 0.014586

PRIMARY outcome

Timeframe: 480 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours Whole Blood	19.30 mcgEq/mL Standard Deviation 2.743
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours Plasma	0.09706 mcgEq/mL Standard Deviation 0.010952

PRIMARY outcome

Timeframe: 648 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 648 Hours Whole Blood	18.71 mcg/mL Standard Deviation 3.597
GBT021601 Concentration in Whole Blood and Plasma at 648 Hours Plasma	0.07343 mcg/mL Standard Deviation 0.011345

PRIMARY outcome

Timeframe: 648 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours Whole Blood	16.32 mcgEq/mL Standard Deviation 2.161
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours Plasma	0.08224 mcgEq/mL Standard Deviation 0.007987

PRIMARY outcome

Timeframe: 816 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 816 Hours Whole Blood	15.20 mcg/mL Standard Deviation 1.553
GBT021601 Concentration in Whole Blood and Plasma at 816 Hours Plasma	0.06894 mcg/mL Standard Deviation 0.011486

PRIMARY outcome

Timeframe: 816 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours Whole Blood	12.93 mcgEq/mL Standard Deviation 1.403
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours Plasma	0.08084 mcgEq/mL Standard Deviation 0.005649

PRIMARY outcome

Timeframe: 984 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 984 Hours Whole Blood	12.60 mcg/mL Standard Deviation 1.715
GBT021601 Concentration in Whole Blood and Plasma at 984 Hours Plasma	0.05919 mcg/mL Standard Deviation 0.006786

PRIMARY outcome

Timeframe: 984 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours Whole Blood	11.087 mcgEq/mL Standard Deviation 1.4815
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours Plasma	0.06646 mcgEq/mL Standard Deviation 0.005689

PRIMARY outcome

Timeframe: 1320 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours Whole Blood	8.772 mcg/mL Standard Deviation 1.1434
GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours Plasma	0.03829 mcg/mL Standard Deviation 0.003602

PRIMARY outcome

Timeframe: 1320 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours Whole Blood	7.599 mcgEq/mL Standard Deviation 1.1109
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours Plasma	0.04387 mcgEq/mL Standard Deviation 0.004128

PRIMARY outcome

Timeframe: 1656 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours Whole Blood	6.253 mcg/mL Standard Deviation 0.9576
GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours Plasma	0.02809 mcg/mL Standard Deviation 0.005965

PRIMARY outcome

Timeframe: 1656 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours Whole Blood	5.528 mcgEq/mL Standard Deviation 1.0078
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours Plasma	0.02835 mcgEq/mL Standard Deviation 0.004387

PRIMARY outcome

Timeframe: 1992 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours Whole Blood	4.283 mcg/mL Standard Deviation 0.7310
GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours Plasma	0.01881 mcg/mL Standard Deviation 0.003921

PRIMARY outcome

Timeframe: 1992 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours Whole Blood	3.667 mcgEq/mL Standard Deviation 0.5431
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours Plasma	0.01909 mcgEq/mL Standard Deviation 0.004378

PRIMARY outcome

Timeframe: 2328 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=6 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours Whole Blood	2.997 mcg/mL Standard Deviation 0.6994
GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours Plasma	0.01407 mcg/mL Standard Deviation 0.007193

PRIMARY outcome

Timeframe: 2328 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=6 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours Whole Blood	2.677 mcgEq/mL Standard Deviation 0.5212
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours Plasma	0.013250 mcgEq/mL Standard Deviation 0.0042927

PRIMARY outcome

Timeframe: 2664 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=5 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours Whole Blood	2.290 mcg/mL Standard Deviation 0.4786
GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours Plasma	NA mcg/mL Standard Deviation NA Mean and SD were not estimated as data was below the lower limit of quantification.

PRIMARY outcome

Timeframe: 2664 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=5 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours Whole Blood	2.064 mcgEq/mL Standard Deviation 0.3699
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours Plasma	0.008206 mcgEq/mL Standard Deviation 0.0031073

PRIMARY outcome

Timeframe: 3240 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=3 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours Whole Blood	1.1523 mcg/mL Standard Deviation 0.38725
GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours Plasma	NA mcg/mL Standard Deviation NA Mean and SD were not estimated as data was below the lower limit of quantification.

PRIMARY outcome

Timeframe: 3240 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=3 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours Whole Blood	0.9463 mcgEq/mL Standard Deviation 0.30792
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours Plasma	NA mcgEq/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

Timeframe: 3576 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=3 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours Whole Blood	0.6097 mcg/mL Standard Deviation 0.52801
GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours Plasma	NA mcg/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

Timeframe: 3576 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=3 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours Whole Blood	0.6733 mcgEq/mL Standard Deviation 0.24908
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours Plasma	NA mcgEq/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

Timeframe: 4248 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=2 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours Whole Blood	NA mcg/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.
GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours Plasma	NA mcg/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

Timeframe: 4248 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=2 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours Whole Blood	0.2745 mcgEq/mL Standard Deviation 0.14637
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours Plasma	NA mcgEq/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

Timeframe: 4920 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=1 Participants 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.
GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours Whole Blood	NA mcg/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.
GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours Plasma	NA mcg/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

Timeframe: 4920 hours post dosing

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here " Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=1 Participants 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.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours Whole Blood	0.2330 mcgEq/mL Standard Deviation NA SD was not estimable as only 1 participant was analyzed.
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours Plasma	NA mcgEq/mL Standard Deviation NA Mean and SD were not estimated as data was below the LLOQ.

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Data are reported as aggregate of all scheduled time points.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces Urine	95.23 milligram equivalents (mgEq) Standard Deviation 10.153
Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces Feces	81.38 milligram equivalents (mgEq) Standard Deviation 12.668

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Data are reported as aggregate of all scheduled time points.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces Urine	47.24 Percentage of administered drug Standard Deviation 5.036
Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces Feces	40.37 Percentage of administered drug Standard Deviation 6.284

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma Whole Blood	824.1 h*mcg/mL Geometric Coefficient of Variation 22.3
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma Plasma	7.393 h*mcg/mL Geometric Coefficient of Variation 20.0

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma Whole Blood	741.8 h*mcgEq/mL Geometric Coefficient of Variation 21.3
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma Plasma	17.92 h*mcgEq/mL Geometric Coefficient of Variation 19.2

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma Whole blood	31481.7 h*mcg/mL Geometric Coefficient of Variation 20.9
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma Plasma	130.35 h*mcg/mL Geometric Coefficient of Variation 16.7

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma Whole blood	27609.6 h*mcgEq/mL Geometric Coefficient of Variation 18.5
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma Plasma	165.7 h*mcgEq/mL Geometric Coefficient of Variation 13.1

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma Whole blood	35290.5 h*mcg/mL Geometric Coefficient of Variation 12.1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma Plasma	150.7 h*mcg/mL Geometric Coefficient of Variation 10.8

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma Whole blood	30636.1 h*mcgEq/mL Geometric Coefficient of Variation 10.5
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma Plasma	179.1 h*mcgEq/mL Geometric Coefficient of Variation 8.8

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma Whole blood	40.06 mcg/mL Geometric Coefficient of Variation 27.1
Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma Plasma	1.468 mcg/mL Geometric Coefficient of Variation 14.0

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma Whole blood	34.05 mcgEq/mL Geometric Coefficient of Variation 20.8
Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma Plasma	2.950 mcgEq/mL Geometric Coefficient of Variation 12.5

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma Whole blood	24.000 Hour (h) Interval 8.0 to 72.03
Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma Plasma	1.000 Hour (h) Interval 0.5 to 1.0

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma Whole blood	24.000 Hour Interval 4.0 to 48.0
Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma Plasma	1.000 Hour Interval 0.5 to 1.0

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma Whole blood	647.8 Hour Standard Deviation 84.51
Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma Plasma	707.1 Hour Standard Deviation 112.32

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma Whole blood	654.7 Hour Standard Deviation 92.46
Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma Plasma	588.9 Hour Standard Deviation 109.92

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine	0.2755 Liter/hour (L/h) Geometric Coefficient of Variation 12.6

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma Whole blood	5.175 Liter (L) Geometric Coefficient of Variation 18.3
Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma Plasma	1300.6 Liter (L) Geometric Coefficient of Variation 15.5

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma Whole blood	5.972 Liter Geometric Coefficient of Variation 15.9
Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma Plasma	906.1 Liter Geometric Coefficient of Variation 14.4

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma Whole blood	0.005713 L/h Geometric Coefficient of Variation 12.1
Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma Plasma	1.338 L/h Geometric Coefficient of Variation 10.8

PRIMARY outcome

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

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

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

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma Whole blood	0.006580 L/h Geometric Coefficient of Variation 10.5
Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma Plasma	1.1258 L/h Geometric Coefficient of Variation 8.8

PRIMARY outcome

Timeframe: 0-6 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours Urine	13.123 mgEq Standard Deviation 4.5812

PRIMARY outcome

Timeframe: 6-12 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours Urine	16.611 mgEq Standard Deviation 4.2333

PRIMARY outcome

Timeframe: 12-24 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours Urine	19.70 mgEq Standard Deviation 4.021

PRIMARY outcome

Timeframe: 0-24 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=7 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours Feces	0.060486 mgEq Standard Deviation 0.1389173

PRIMARY outcome

Timeframe: 24 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours Urine	23.19 mgEq Standard Deviation 4.305
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours Feces	24.25 mgEq Standard Deviation 9.726

PRIMARY outcome

Timeframe: 48 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours Urine	25.50 mgEq Standard Deviation 4.727
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours Feces	33.17 mgEq Standard Deviation 7.021

PRIMARY outcome

Timeframe: 72 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours Urine	27.55 mgEq Standard Deviation 5.112
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours Feces	35.06 mgEq Standard Deviation 8.909

PRIMARY outcome

Timeframe: 96 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours Urine	29.35 mgEq Standard Deviation 5.504
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours Feces	37.31 mgEq Standard Deviation 8.103

PRIMARY outcome

Timeframe: 120 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours Urine	30.97 mgEq Standard Deviation 5.791
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours Feces	40.54 mgEq Standard Deviation 4.600

PRIMARY outcome

Timeframe: 144 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours Urine	32.88 mgEq Standard Deviation 6.151
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours Feces	39.51 mgEq Standard Deviation 8.832

PRIMARY outcome

Timeframe: 168 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours Urine	34.82 mgEq Standard Deviation 6.438
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours Feces	40.87 mgEq Standard Deviation 7.673

PRIMARY outcome

Timeframe: 192 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours Urine	36.72 mgEq Standard Deviation 6.695
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours Feces	44.39 mgEq Standard Deviation 5.139

PRIMARY outcome

Timeframe: 216 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours Urine	38.48 mgEq Standard Deviation 6.926
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours Feces	43.09 mgEq Standard Deviation 9.219

PRIMARY outcome

Timeframe: 240 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours Urine	40.22 mgEq Standard Deviation 7.197
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours Feces	43.54 mgEq Standard Deviation 8.212

PRIMARY outcome

Timeframe: 264 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours Urine	41.99 mgEq Standard Deviation 7.402
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours Feces	45.31 mgEq Standard Deviation 8.482

PRIMARY outcome

Timeframe: 288 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours Urine	43.65 mgEq Standard Deviation 7.589
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours Feces	44.72 mgEq Standard Deviation 7.324

PRIMARY outcome

Timeframe: 312 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours Feces	46.29 mgEq Standard Deviation 9.018
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours Urine	45.06 mgEq Standard Deviation 7.759

PRIMARY outcome

Timeframe: 336 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours Urine	46.50 mgEq Standard Deviation 7.899
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours Feces	50.24 mgEq Standard Deviation 5.880

PRIMARY outcome

Timeframe: 360 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours Urine	47.92 mgEq Standard Deviation 8.085
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours Feces	48.56 mgEq Standard Deviation 8.315

PRIMARY outcome

Timeframe: 384 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours Urine	49.41 mgEq Standard Deviation 8.242
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours Feces	52.20 mgEq Standard Deviation 6.116

PRIMARY outcome

Timeframe: 408 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours Urine	50.87 mgEq Standard Deviation 8.418
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours Feces	49.97 mgEq Standard Deviation 9.261

PRIMARY outcome

Timeframe: 432 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours Urine	52.24 mgEq Standard Deviation 8.469
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours Feces	50.84 mgEq Standard Deviation 9.215

PRIMARY outcome

Timeframe: 456 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours Urine	53.59 mgEq Standard Deviation 8.564
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours Feces	53.99 mgEq Standard Deviation 6.398

PRIMARY outcome

Timeframe: 480 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours Urine	54.81 mgEq Standard Deviation 8.616
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours Feces	52.89 mgEq Standard Deviation 9.678

PRIMARY outcome

Timeframe: 504 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours Urine	56.00 mgEq Standard Deviation 8.649
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours Feces	53.22 mgEq Standard Deviation 9.709

PRIMARY outcome

Timeframe: 528 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours Urine	57.15 mgEq Standard Deviation 8.734
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours Feces	56.23 mgEq Standard Deviation 6.834

PRIMARY outcome

Timeframe: 552 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours Urine	58.19 mgEq Standard Deviation 8.845
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours Feces	55.14 mgEq Standard Deviation 9.750

PRIMARY outcome

Timeframe: 576 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours Urine	59.25 mgEq Standard Deviation 9.013
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours Feces	55.39 mgEq Standard Deviation 9.766

PRIMARY outcome

Timeframe: 600 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours Urine	60.20 mgEq Standard Deviation 9.159
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours Feces	58.26 mgEq Standard Deviation 7.116

PRIMARY outcome

Timeframe: 624 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours Feces	57.17 mgEq Standard Deviation 9.867
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours Urine	61.13 mgEq Standard Deviation 9.230

PRIMARY outcome

Timeframe: 648 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. ere "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours Urine	62.18 mgEq Standard Deviation 9.313
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours Feces	59.51 mgEq Standard Deviation 8.648

PRIMARY outcome

Timeframe: 816 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours Urine	67.24 mgEq Standard Deviation 8.848
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours Feces	62.99 mgEq Standard Deviation 11.632

PRIMARY outcome

Timeframe: 984 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours Urine	74.37 mgEq Standard Deviation 9.568
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours Feces	67.30 mgEq Standard Deviation 11.537

PRIMARY outcome

Timeframe: 1320 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours Urine	83.07 mgEq Standard Deviation 9.068
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours Feces	72.95 mgEq Standard Deviation 12.135

PRIMARY outcome

Timeframe: 1656 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours Urine	89.48 mgEq Standard Deviation 9.168
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours Feces	76.42 mgEq Standard Deviation 13.642

PRIMARY outcome

Timeframe: 1992 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=8 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours Urine	93.46 mgEq Standard Deviation 9.065
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours Feces	79.01 mgEq Standard Deviation 14.557

PRIMARY outcome

Timeframe: 2328 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified row.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=6 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours Urine	92.85 mgEq Standard Deviation 7.592
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours Feces	84.14 mgEq Standard Deviation 15.744

PRIMARY outcome

Timeframe: 2664 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=2 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours Urine	100.08 mgEq Standard Deviation 12.033
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours Feces	59.86 mgEq Standard Deviation 0.613

PRIMARY outcome

Timeframe: 3240 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=3 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours Feces	69.27 mgEq Standard Deviation 13.344
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours Urine	98.36 mgEq Standard Deviation 10.969

PRIMARY outcome

Timeframe: 3576 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=3 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours Urine	98.96 mgEq Standard Deviation 11.161
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours Feces	69.62 mgEq Standard Deviation 13.175

PRIMARY outcome

Timeframe: 4248 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified row.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=2 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours Urine	93.30 mgEq Standard Deviation 3.569
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours Feces	85.10 mgEq Standard Deviation NA SD was not estimable as only 1 participant was analyzed.

PRIMARY outcome

Timeframe: 4920 hours post dose

Population: PK analysis set included all participants who had received 1 dose of GBT021601 and provided at least 1 measurable post dose PK concentration of GBT021601 or total radioactivity in whole blood or plasma. Here "Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=1 Participants 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.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours Urine	96.31 mgEq Standard Deviation NA SD was not estimable as only 1 participant was analyzed.
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours Feces	63.87 mgEq Standard Deviation NA SD was not estimable as only 1 participant was analyzed.

SECONDARY outcome

Timeframe: From Day 1 up to maximum of Day 57

Population: Safety analysis set included all participants who had received 1 dose of GBT021601.

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).

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	4 Participants

SECONDARY outcome

Timeframe: Day 1 of dosing to Day 207

Population: Safety analysis set included all participants who had received 1 dose of GBT021601.

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.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Number of Participants With Clinically Significant Laboratory Values	0 Participants

SECONDARY outcome

Timeframe: Day 1 of dosing to Day 207

Population: Safety analysis set included all participants who had received 1 dose of GBT021601.

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.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Number of Participants With Clinically Significant Vital Signs Values	0 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Safety analysis set included all participants who had received 1 dose of GBT021601.

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.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Number of Participants With Clinically Significant ECG Values	0 Participants

SECONDARY outcome

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

Population: Safety analysis set included all participants who had received 1 dose of GBT021601.

Physical Examination test included body weight and height. physical examination was conducted at screening. Clinical significance was judged by investigator.

Outcome measures

Measure	GBT021601+[14C]-GBT021601 n=9 Participants 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.
Number of Participants With Clinically Significant Physical Examination Values	0 Participants

Adverse Events

GBT021601+[14C]-GBT021601

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GBT021601+[14C]-GBT021601 n=9 participants at risk 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.
Nervous system disorders Headache	22.2% 2/9 • 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.
Gastrointestinal disorders Nausea	11.1% 1/9 • 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.
Infections and infestations COVID-19	11.1% 1/9 • 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.
Injury, poisoning and procedural complications Animal scratch	11.1% 1/9 • 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.
Reproductive system and breast disorders Polymenorrhoea	11.1% 1/9 • 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.
Skin and subcutaneous tissue disorders Dermatitis contact	11.1% 1/9 • 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.

Additional Information

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Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER