A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension

Phase 1/2 Completed 20 enrolled Eli Lilly and Company

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.

Timeline

Start: 2012-07-17
Primary completion: 2017-04-21
Completion: 2019-04-03

Publications

Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2022 Feb;61(2):249-262. doi: 10.1007/s40262-021-01052-8. Epub 2021 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tadalafil	Small molecule	8 mg	Oral
Subject	Tadalafil	Small molecule	10 mg	Oral
Subject	Tadalafil	Small molecule	15 mg	Oral
Subject	Tadalafil	Small molecule	20 mg	Oral
Subject	Tadalafil	Small molecule	40 mg	Oral

A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension

Summary

Timeline

Publications

Drugs

Indications