This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Pharmaceutical form: Tablet Route of administration: Oral
Pharmaceutical form: Tablet Route of administration: Oral
Pharmaceutical form: Tablet Route of administration: Oral
FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400002
Dallas, Texas, United States
RECRUITINGFORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400001
Madison, Wisconsin, United States
RECRUITINGChange from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Time frame: Baseline to day 2
Change from baseline in heart rate (HR)
Time frame: Day 1 to Day 2
Change from baseline in QT interval
Time frame: Baseline to day 2 of each period
Change from baseline in QT interval corrected using the Bazett formula (QTcB)
Time frame: Baseline to day 2 of each period
Change from baseline in population specific QT correction (QTcN) interval
Time frame: Baseline to day 2 of each period
Change from baseline in QRS interval
Time frame: Baseline to day 2 of each period
Change from baseline in PR interval
Time frame: Baseline to day 2 of each period
Safety for electrocardiogram (ECG) parameters
Time frame: Baseline to day 83
Maximum plasma concentration (Cmax) for balinatunfib
Time frame: Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib
Time frame: Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib
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Time frame: Baseline to day 6 of each period
Maximum plasma concentration (Cmax) for balinatunfib metabolite M8
Time frame: Baseline to day 6 of each period
Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8
Time frame: Baseline to day 6 of each period
Area under the curve (AUC) for balinatunfib metabolite M8
Time frame: Baseline to day 6 of each period
Number of participants experiencing treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and serious adverse events (SAEs)
Time frame: Baseline to Day 83
Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality)
Time frame: Baseline to Day 83