Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)

July 17, 2024 updated by: GlaxoSmithKline

A Randomized, Double-blind, Placebo Controlled, Single and Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Inhaled GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)

This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants. The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between 40 and 70 years of age.
  • Confirmed diagnosis of COPD for greater than (>) 6 months.
  • Participant is a smoker or an ex-smoker with a smoking history of at least 10 pack years.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and agrees to use contraceptives during the study (for women of childbearing potential only).

Exclusion Criteria:

  • Participant has poorly controlled or unstable COPD.
  • Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled.
  • Participant has had a respiratory tract infection treated with antibiotics within 4 weeks prior to screening.
  • Participant requires regular treatment with oral corticosteroids or has received a course of oral or parenteral corticosteroids within 4 weeks prior to screening.
  • Participant requires long-term oxygen therapy.
  • Current enrolment or past participation in a clinical trial within 30 days before this study starts.
  • Positive tests for human immunodeficiency virus (HIV), hepatitis B and C, or Coronavirus disease-19 (COVID-19).
  • Positive pre-study drug (except for as results of opioids prescribed for medical reasons and/or inadvertent consumption of poppy seeds) /alcohol screening result.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD
Eligible participants will receive a single dose (SD) of GSK3923868 500 microgram (mcg) in Treatment Period 1 followed by a single dose of placebo matching GSK3923868 in Treatment Period 2. Participants will also receive a repeat dose (RD) of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: Placebo
Placebo will be administered
Drug: GSK3923868
GSK3923868 will be administered
Experimental: GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD
Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of placebo matching GSK3923868 in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: Placebo
Placebo will be administered
Drug: GSK3923868
GSK3923868 will be administered
Experimental: GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD
Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: GSK3923868
GSK3923868 will be administered
Experimental: Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD
Eligible participants will receive a single dose of placebo matching GSK3923868 in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: Placebo
Placebo will be administered
Drug: GSK3923868
GSK3923868 will be administered

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868
Time Frame: Up to 18 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
Up to 18 days
Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868
Time Frame: Up to 29 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
Up to 29 days
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868
Time Frame: Up to 18 days
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
Up to 18 days
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868
Time Frame: Up to 29 days
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
Up to 29 days
Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868
Time Frame: Up to 29 days
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine by dipstick. Number of participants with clinically significant changes in urinalysis parameters were reported. Clinical significance was determined by the investigator.
Up to 29 days
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868
Time Frame: Up to 18 days
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
Up to 18 days
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868
Time Frame: Up to 29 days
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
Up to 29 days
Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868
Time Frame: Up to 18 days
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
Up to 18 days
Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868
Time Frame: Up to 29 days
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
Up to 29 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose
Time Frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) of GSK3923868 for Single Dose
Time Frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Blood samples were collected at the indicated time points for PK analysis of GSK3923868. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration values were reported.
Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose
Time Frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose
Time Frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose
Time Frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Cmax of GSK3923868 for Repeat Dose
Time Frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Tmax of GSK3923868 for Repeat Dose
Time Frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 214075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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