The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Number of Participants with an Adverse Event (AE)
Incidence of AEs, including serious AEs assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.5.0. Clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms, vital signs, and physical examinations will be recorded as AEs.
Time frame: 16 weeks
Maximum Observed Plasma Concentration (Cmax) of TTI-101
Time frame: Day 1 to Week 12
Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
Time frame: Day 1 to Week 12
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
Time frame: Day 1 to Week 12
Trough Plasma Concentration (Cτ) of TTI-101
Time frame: Day 1 to Week 12
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