Trials / Completed
CompletedNCT02593539
Safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI
An Open-label, Single Arm Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nemiralisib | Participants will be administered nemiralisib |
Timeline
- Start date
- 2016-07-22
- Primary completion
- 2020-06-04
- Completion
- 2020-06-04
- First posted
- 2015-11-02
- Last updated
- 2021-06-18
- Results posted
- 2021-06-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02593539. Inclusion in this directory is not an endorsement.