Clinical trial NCT05718687: A GBT021601 ADME Microtracer Study in Healthy Volunteers
Official title: A PHASE 1 STUDY TO ASSESS THE MASS BALANCE, EXCRETION, AND PHARMACOKINETICS OF [14C]-GBT021601, AN ORAL HEMOGLOBIN SPOLYMERIZATION INHIBITOR, IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sickle Cell Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.

Detailed description: This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening.
* Body weight ≥ 50 kg at screening
* Females must be nonlactating and nonpregnant (as confirmed by a negative serum pregnancy test at screening and admission for all females), or of nonchildbearing potential (ie, either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal \[defined as at least 12 months no menses, and confirmed by a follicle-stimulating hormone test, at screening\]).
* Creatinine clearance (glomerular filtration rate) as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula: ≥90 mL/min, at screening.

Exclusion Criteria:

* History or presence of conditions which, in the opinion of the Investigator, are known to interfere with the ADME of drugs, such as previous surgery on the gastrointestinal tract (including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas). Participants who have a history of appendectomy are eligible for enrollment.
* History of chronic constipation, or recent complaints of an irregular defecation
* Significant and/or acute illness at screening or within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
* Known personal or family history of congenital long QT syndrome or known family history of sudden death.
* Participation in another ADME study with a radiation burden \>0.1 mSv in the period of 1 year prior to screening.

Primary outcomes:
measure: GBT021601 Concentration in Whole Blood and Plasma at Predose
timeFrame: Predose (within 60 minutes prior to GBT021601 dosing)
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose
timeFrame: Predose (within 60 minutes prior to 14C-GBT021601 dosing)
measure: GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours
timeFrame: 0.25 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours
timeFrame: 0.25 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours
timeFrame: 0.50 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours
timeFrame: 0.50 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 1 Hours
timeFrame: 1 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours
timeFrame: 1 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 2 Hours
timeFrame: 2 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours
timeFrame: 2 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 3 Hours
timeFrame: 3 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours
timeFrame: 3 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 4 Hours
timeFrame: 4 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours
timeFrame: 4 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 6 Hours
timeFrame: 6 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours
timeFrame: 6 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 8 Hours
timeFrame: 8 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours
timeFrame: 8 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 12 Hours
timeFrame: 12 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours
timeFrame: 12 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 24 Hours
timeFrame: 24 hours post dosing on Day 1
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours
timeFrame: 24 hours post dosing on Day 1
measure: GBT021601 Concentration in Whole Blood and Plasma at 48 Hours
timeFrame: 48 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours
timeFrame: 48 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 72 Hours
timeFrame: 72 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours
timeFrame: 72 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 96 Hours
timeFrame: 96 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours
timeFrame: 96 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 144 Hours
timeFrame: 144 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours
timeFrame: 144 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 168 Hours
timeFrame: 168 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours
timeFrame: 168 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 312 Hours
timeFrame: 312 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours
timeFrame: 312 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 480 Hours
timeFrame: 480 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours
timeFrame: 480 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 648 Hours
timeFrame: 648 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours
timeFrame: 648 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 816 Hours
timeFrame: 816 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours
timeFrame: 816 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 984 Hours
timeFrame: 984 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours
timeFrame: 984 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours
timeFrame: 1320 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours
timeFrame: 1320 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours
timeFrame: 1656 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours
timeFrame: 1656 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours
timeFrame: 1992 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours
timeFrame: 1992 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours
timeFrame: 2328 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours
timeFrame: 2328 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours
timeFrame: 2664 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours
timeFrame: 2664 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours
timeFrame: 3240 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours
timeFrame: 3240 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours
timeFrame: 3576 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours
timeFrame: 3576 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours
timeFrame: 4248 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours
timeFrame: 4248 hours post dosing
measure: GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours
timeFrame: 4920 hours post dosing
measure: 14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours
timeFrame: 4920 hours post dosing
measure: Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
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
measure: Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma
timeFrame: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
measure: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma
timeFrame: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
measure: Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma
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
measure: Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma
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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma
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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma
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
measure: Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma
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
measure: Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma
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
measure: Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma
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
measure: Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma
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
measure: Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma
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
measure: Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma
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
measure: Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine
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
measure: Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma
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
measure: Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma
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
measure: Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma
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
measure: Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma
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
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours
timeFrame: 0-6 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours
timeFrame: 6-12 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours
timeFrame: 12-24 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours
timeFrame: 0-24 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours
timeFrame: 24 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours
timeFrame: 48 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours
timeFrame: 72 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours
timeFrame: 96 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours
timeFrame: 120 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours
timeFrame: 144 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours
timeFrame: 168 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours
timeFrame: 192 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours
timeFrame: 216 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours
timeFrame: 240 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours
timeFrame: 264 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours
timeFrame: 288 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours
timeFrame: 312 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours
timeFrame: 336 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours
timeFrame: 360 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours
timeFrame: 384 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours
timeFrame: 408 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours
timeFrame: 432 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours
timeFrame: 456 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours
timeFrame: 480 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours
timeFrame: 504 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours
timeFrame: 528 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours
timeFrame: 552 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours
timeFrame: 576 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours
timeFrame: 600 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours
timeFrame: 624 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours
timeFrame: 648 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours
timeFrame: 816 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours
timeFrame: 984 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours
timeFrame: 1320 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours
timeFrame: 1656 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours
timeFrame: 1992 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours
timeFrame: 2328 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours
timeFrame: 2664 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours
timeFrame: 3240 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours
timeFrame: 3576 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours
timeFrame: 4248 hours post dose
measure: Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours
timeFrame: 4920 hours post dose
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Day 1 up to maximum of Day 57
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: Day 1 of dosing to Day 207
measure: Number of Participants With Clinically Significant Vital Signs Values
timeFrame: Day 1 of dosing to Day 207
measure: Number of Participants With Clinically Significant ECG Values
timeFrame: Day 1
measure: Number of Participants With Clinically Significant Physical Examination Values
timeFrame: Screening (-28 Day to -2 Day, day with respect to dosing)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON Early Phase Clinic, LLC
Study officials:
affiliation: Pfizer
name: Pfizer Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: