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Respiratory Tract InfectionsPhase 1NCT06577597

Safety, Tolerability and Blood Sampling of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese, Japanese and European Ancestry

A Phase 1 study testing GSK3923868 in people with Respiratory Tract Infections, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to understand how the drug GSK3923868 works in the bodies of healthy people from Japanese, Chinese, and European ancestries. This is important to meet the rules for including these groups in future worldwide studies. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Tract Infections
What is being tested?
GSK3923868
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
2 Sep 2024to 1 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessment, pulmonary function testing and laboratory tests
  • Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants
  • Body Mass Index (BMI) within the range of 18.0-28.0 kilograms per square meter (kg/m^2) (inclusive)
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and is a Woman of non-childbearing potential (WONCBP); or Woman of childbearing potential (WOCBP) and using an acceptable contraceptive method; or A WOCBP must have a negative highly sensitive pregnancy test within 30 days before the first dose of study intervention
  • Informed consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Participants of Chinese ancestry are eligible if they are born in mainland China, Hong Kong or Taiwan; descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents; have lived outside mainland China, Hong Kong or Taiwan for less than 10 years at the time of screening
  • Participants of Japanese ancestry are eligible if they are born in Japan, descendent of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents; have lived outside Japan less than 10 years at the time of screening
  • Participants of European ancestry are eligible if they self-identified as being European ancestry (that is, from the original people of Europe) irrespective of place of birth and current place of residence; descendent of 4 grandparents and 2 parents of European ancestry

Who cannot join

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
  • Serum Alanine transaminase (ALT) and Aspartate Aminotransferase (AST) above Upper limit of normal (ULN)
  • Total Bilirubin above ULN (isolated bilirubin above ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than [<] 35 percent [%])
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • QTcF greater than (>) 450 milliseconds (msec) at Screening visit based on the average of triplicate ECGs
  • Past or intended use of over-the-counter or prescription medication, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the first dose of study treatment, unless in the opinion of the investigator and the GSK Medical Monitor (if necessary), the medication will not interfere with the study procedures or compromise participant safety
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  • Recent donation of blood or blood products such that participation in this study would result in loss of blood in excess of 500 mL within a 60-day period.
  • Exposure to more than 4 new chemical or molecular entities within 12 months before the first dosing day
  • Current enrolment or past participation in a clinical trial and has received an investigational product within the following time period before the first dosing day in this study: 45 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
  • FEV1 <80% predicted normal value at Screening
  • Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention
  • Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention
  • Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention
  • Positive pre-study drug/alcohol screen
  • Positive HIV antibody test
  • Current or history of drug abuse
  • Current or previous use of tobacco- or nicotine-containing products (e.g. cigarettes, nicotine patches or electronic devices) within 6 months before screening and/or have a smoking pack history of >5 pack years
  • Positive urine cotinine test indicative of recent smoking at Screening or admission to the clinical research unit
  • History of regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >14 units for males and females
  • Sensitivity to the study intervention or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    Middlesex, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Tolerability and Pharmacokinetics of Single Doses of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese, Japanese and European Ancestry

This study is designed to understand how the drug GSK3923868 works in the bodies of healthy people from Japanese, Chinese, and European ancestries. This is important to meet the rules for including these groups in future worldwide studies. The study is carefully planned to reduce differences that might come from comparing results across different studies and locations, making it easier to compare results between these ethnic groups. The main goal is to check if GSK3923868 is safe and easy to tolerate when given as a single inhaled dose to healthy people from these three ancestries. The study also wants to see how the drug moves in the blood after a single inhaled dose in these groups. On the first day of the study, participants will be randomly chosen to receive either a single dose of GSK3923868 or a placebo. The aim is to have enough people take part so that 10 healthy people from each ancestry group (a total of 30 people) can successfully finish the study. Should a participant withdraw from the study before completion, the GSK Medical Monitor and the investigator may select a replacement. The replacement participant will be assigned the same treatment as the original participant.

Being tested
GSK3923868, Placebo
Keywords
GSK3923868, Safety, Tolerability, Pharmacokinetics, Healthy participants, Phosphatidylinositol 4-kinase beta (PI4KB)
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK3923868Drug

    Participants will receive single dose of GSK3923868.

  • PlaceboDrug

    Participants will receive single dose of Placebo.

Study groups in NCT06577597
Study groupRoleWhat they receive
GSK3923868ExperimentalParticipants from Chinese, Japanese and European ancestries will receive single dose of GSK3923868.
Receives: Drug: GSK3923868
PlaceboPlacebo comparatorParticipants from Chinese, Japanese and European ancestries will receive single dose of placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse events (AE)

    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

    Measured: Up to Day 14 (End of follow up)

  2. Number of Participants with Serious Adverse events (SAE)

    An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; abnormal pregnancy outcome; or is a suspected transmission of any infectious agent via an authorized medicinal product.

    Measured: Up to Day 14 (End of follow up)

  3. Number of Participants with Clinically Significant Changes in Laboratory Values

    Clinically significant changes in laboratory values (Clinical Chemistry, Haematology and Coagulation Clinical Chemistry, Haematology, and Coagulation) will be assessed.

    Measured: Up to Day 14 (End of follow up)

  4. Number of Participants with Clinically Significant Changes in Laboratory values

    Clinically significant changes in Laboratory values (Urinalysis) will be assessed.

    Measured: Up to Day 14 (End of follow up)

  5. Number of Participants with Clinically Significant Changes in Vital signs

    Clinically significant changes in Vital signs (systolic and diastolic blood pressure, heart rate, respiration rate, pulse oximetry and oral temperature) will be assessed.

    Measured: Up to Day 14 (End of follow up)

  6. Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

    Clinically significant changes in 12-lead ECG will be assessed.

    Measured: Up to Day 14 (End of follow up)

  7. Number of Participants with Clinically Significant Changes in Spirometry Measurements

    Number of participants with clinically significant changes in Spirometry measurements.

    Measured: On Day 14 (End of follow up)

  8. Area Under the Plasma GSK3923868 Concentration Versus Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-t]) of GSK3923868

    Blood samples will be collected at the specified timepoints for the pharmacokinetics (PK) assessments.

    Measured: Up to Day 4

  9. Area under the Plasma GSK3923868 Concentration versus Time Curve from Time zero to Infinity (AUC[0-inf]) of GSK3923868

    Blood samples will be collected at the specified timepoints for the PK assessments.

    Measured: Up to Day 4

  10. Maximum Observed GSK3923868 Plasma Concentration (Cmax) of GSK3923868

    Blood samples will be collected at the specified timepoints for the PK assessments.

    Measured: Up to Day 4

  11. Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3923868

    Blood samples will be collected at the specified timepoints for the PK assessments.

    Measured: Up to Day 4

  12. Terminal Half-life (T1/2) of GSK3923868

    Blood samples will be collected at the specified timepoints for the PK assessments.

    Measured: Up to Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start2 Sep 2024
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577597
Sponsor's protocol ID
218320
Status last verified
Dec 2024
First submitted
27 Aug 2024
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK3923868 in people with Respiratory Tract Infections, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse events (AE) (time frame: Up to Day 14 (End of follow up)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06577597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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