Safety, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of Repeat Doses

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

This is an open-label study conducted to investigate safety, pharmacokinetics and pharmacodynamics of repeat doses of inhaled nemiralisib (NEMI) in participants with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110 delta-activating mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI)

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT03383380` - Rapamycin Treatment for Activated Phosphoinositide 3-Kinase δ Syndrome	Phase 1/Phase 2

NCT number	NCT02593539
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 2
Start date	July 22, 2016
Completion date	June 4, 2020

Safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms