Recruiting

Study Description:

This is a multi-center, non-randomised, open-label, uncontrolled, single group study to investigate the safety and pharmacokinetics (PK) during 84 days repeat dosing treatment with 1000 micrograms (mcg) of inhaled GSK2269557 in addition to standard of care, in subjects with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110delta-activating mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI). To date GSK2269557 has been administered to healthy subjects (smokers and non smokers), subjects with: stable Chronic Obstructive Pulmonary Disease (COPD); subjects experiencing a COPD exacerbation; and subjects with persistent, uncontrolled asthma. As this study is the first administration of GSK2269557 to subjects with APDS, this study will provide safety, tolerability, efficacy and pharmacokinetic data in this patient population. Up to 20 subjects will be enrolled into the study. The total duration of the study is approximately 30 weeks, including pre-screening/screening and follow-up.

GSK Study ID:

204745


ClinicalTrials.gov Identifier:

NCT02593539


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Immune & Inflammatory - Other

Product

nemiralisib

Collaborators

N/A


Date

July 2016 to May 2020

Type

Interventional

Phase

2


Gender

All

Age

18 years - N/A

Accepts Healthy Volunteers

No


Study Documents

No documents available
This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

United Kingdom, Cambridge CB2 0GGRecruiting

Study Design

  • Primary Purpose: Treatment
  • Allocation: Not Available
  • Study Design: Single Group Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Number of subjects with any adverse events (AE)
    Timeframe: Up to 6 months

  • Systolic and diastolic blood pressure as a measure of safety
    Timeframe: Up to 7.5 months

  • Temperature as a measure of safety
    Timeframe: Up to 7.5 months

  • Pulse rate as a measure of safety
    Timeframe: Up to 7.5 months

  • Respiratory rate as a measure of safety
    Timeframe: Up to 7.5 months

  • 12-lead electrocardiogram (ECG) as a measure of safety
    Timeframe: Up to 7.5 months

  • Composite of hematology parameters as a measure of safety
    Timeframe: Up to 7.5 months

  • Composite of clinical chemistry parameters as a measure of safety
    Timeframe: Up to 7.5 months

  • Composite of urinalysis parameters as a measure of safety
    Timeframe: Up to 7.5 months

  • Spirometry: Forced expiratory volume in one second (FEV1)
    Timeframe: Up to 7.5 months

Secondary Outcomes:

  • GSK2269557 trough plasma concentration following single and repeated treatment
    Timeframe: Pre-dose, 5 minutes, 3 hours and 24 hours post-dose on Day 1 and pre-dose on Days 2, 14, and 83 and early withdrawal

Arms:
  • 1

Interventions:

  • Drug: GSK2269557 DPI 500 mcg

Keyword:

  • APDS, Safety, Pharmacokinetics, GSK2269557, PASLI
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 20