The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
21
100 mg per tablet, dosed once daily
100 mg per capsule, dosed once daily
Research Site
Adelaide, South Australia, Australia
Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib)
Time frame: Day 1 and Day 7
Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib)
Time frame: Day 1 and Day 7
Nintedanib absorption to time t (AUC0-t) after administration alone and after coadministration with ENV-101 (taladegib)
AUC represents "area under the concentration-time curve" and measures the amount of drug that is present in the blood from the time of administration to a given time t
Time frame: Day 1 and Day 7
Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib)
Time frame: Day 1 and Day 7
Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib)
Time frame: Day 1 and Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.