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PK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212) — OraGrowtH212  

Growth Hormone Deficiency Clinical Trial

Official title:
A Single-Center, Randomized, Open-Label, Parallel Arm Study of Daily Oral LUM-201 in Naive-to-Treatment, Prepubertal Children With Idiopathic Pediatric Growth Hormone Deficiency (PGHD)

Clinical Trial Summary

The goals of this single site trial are to study the pharmacokinetics (PK) and pharmacodynamics of LUM-201 and effects of LUM-201 administration on growth hormone release over time in children with idiopathic pediatric growth hormone deficiency (PGHD).

Clinical Trial Description

This trial will have a single screening visit to assess if subjects are eligible to start study therapy. Once subjects have completed screening, and if they are determined to be eligible, they will return to the clinic for a 12-hour pulsatility study. On Day Two of the trial, subjects will be randomized to receive one of two oral daily doses of LUM-201 and PK samples will be collected. All subjects will have an equal chance of being placed in either of the two groups. The trial consists of treatment until subjects achieve near adult height. After screening, subjects will return to the clinic monthly for the first 6 visits and every three months thereafter. At most clinic visits, subjects will have a physical exam, blood and urine collections. At the Month 6 visit subjects will repeat the 12-hour pulsatility and PK studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04806854
Study type Interventional
Source Lumos Pharma
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 14, 2021
Completion date July 2030
View Details
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