Idiopathic Pulmonary FibrosisPhase 1NCT06625489
A Study to Evaluate the Safety, Tolerability and Blood Levels of GSK3915393 Administered to Healthy Participants of Chinese, Japanese and European Ancestry and to Assess Effects of GSK3915393 on Nintedanib
A Phase 1 study testing Nintedanib and GSK3915393 in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
GSK3915393 is a new medicine which is being developed for a chronic lung disease called Idiopathic Pulmonary Fibrosis (IPF). This is a healthy participant study which has two parts. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Nintedanib and GSK3915393
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2024to 25 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
- For Part A and Part B:
- Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessments, and laboratory tests Body weight at least 50.0 kilograms (kg) (110 pounds [lbs]) for male participants (Part A and Part B) or at least 45.0 kg (99 lbs) for female participants (Part A only) Body mass index (BMI) within the range of 18.0 to 28.0 kilogram per square meter (kg/m^2) (inclusive) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
- For Part A:
- Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is a woman of non-childbearing potential (WONCBP) Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method prior to and during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (for example, noncompliance, recently initiated in relationship to the first dose of study intervention) A WOCBP must have a negative highly sensitive pregnancy test within 30 days before the first dose of study intervention Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong or Taiwan; descendant of four ethnic Chinese grandparents and two ethnic Chinese parents; and have lived outside China, Hong Kong or Taiwan for less than 10 years at the time of screening Participants of Japanese ancestry are eligible if born in Japan; Descendant of four ethnic Japanese grandparents and two ethnic Japanese parents; and have lived outside Japan for less than 10 years at the time of screening Participants of European ancestry are eligible if Self-identified as being of European ancestry (i.e. from the original peoples of Europe) irrespective of current place of residence; and descendant of four grandparents and two 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 Participants with systolic blood pressure (BP) greater than (>) 140 millimeter of mercury (mmHg) or diastolic BP > 90 mmHg at screening or pulse rate outside the range of 40 to 100 beats per minute (bpm) will be excluded from the study Alanine transaminase (ALT) or aspartate aminotransferase (AST) >1× upper limit of normal (ULN) Total bilirubin >1.5×ULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5×ULN as long as direct bilirubin is less than or equal to (≤) 1.5×ULN Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) QT interval corrected (QTc) >450 milliseconds (msec) at Screening visit based on the average of triplicate ECGs Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, probiotics, antacids, 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) prior to the first dose of study intervention, unless in the opinion of the Investigator and the Medical Monitor, the medication will not interfere with the study procedures or compromise participant safety
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Cypress, California, 90630
GSK Investigational Site
Las Vegas, Nevada, 89113
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3915393 Administered as a Single Dose to Healthy Participants of Chinese, Japanese and European Ancestry, and to Assess the Effects of GSK3915393, on the Pharmacokinetics of Nintedanib
GSK3915393 is a new medicine which is being developed for a chronic lung disease called Idiopathic Pulmonary Fibrosis (IPF). This is a healthy participant study which has two parts. Part A will assess the safety, tolerability, and blood levels of GSK3915393 given as a single dose to healthy participants of Chinese, Japanese, and European ancestries. Part B is a drug-drug interaction (DDI) study that examines the effect of a single dose of GSK3915393 on the blood levels of a single dose of nintedanib, which is an approved drug for IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Part A: Placebo, Nintedanib, GSK3915393
- Keywords
- GSK3915393, Nintedanib, Drug-drug interaction, P-gp inhibitor, Idiopathic pulmonary fibrosis, Interstitial lung disease, Japanese, Chinese, European
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A: PlaceboDrug
Placebo will be administered.
NintedanibDrug
Nintedanib will be administered.
GSK3915393Drug
GSK3915393 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part A: GSK3915393 | Experimental | Participants from Chinese, Japanese, and European ancestries will be randomized to receive GSK3915393 under fasting condition. Receives: Drug: GSK3915393 |
| Part A: Placebo | Placebo comparator | Participants from Chinese, Japanese, and European ancestries will be randomized to receive placebo under fasting condition. Receives: Drug: Part A: Placebo |
| Part B: Nintedanib followed by Nintedanib plus GSK3915393 | Experimental | Male participants will be randomized to receive Nintedanib in Period 1 followed by co-administration of Nintedanib and GSK3915393 in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. Receives: Drug: Nintedanib; Drug: GSK3915393 |
| Part B: Nintedanib plus GSK3915393 followed by Nintedanib | Experimental | Male participants will be randomized to receive co-administration of Nintedanib and GSK3915393 in Period 1 followed by Nintedanib in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. Receives: Drug: Nintedanib; Drug: GSK3915393 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants with Adverse Events (AEs)
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 10
Part A: Number of Participants with Serious Adverse Events (SAEs)
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 10
Part A: Number of Participants with Clinically Significant Changes in Clinical Laboratory Values
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
Measured: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in Vital signs (temperature, systolic and diastolic blood pressure [BP], pulse rate and respiratory rate [RR]) will be assessed.
Measured: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Measured: Up to Day 10
Part A: Area Under the Plasma Concentration Versus Time Curve From Time Zero To t (AUC [0-t]) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Measured: Up to 36 hours post dose
Part A: Area Under the Plasma Concentration Versus Time Curve From Time Zero To Infinity (AUC [0-inf]) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Measured: Up to 36 hours post dose
Part A: Maximum Observed Plasma Concentration (Cmax) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Measured: Up to 36 hours post dose
Part A: Time to Cmax (Tmax) of GSK3915393
Blood sample will be collected to evaluate time of maximum plasma concentration of GSK3915393.
Measured: Up to 36 hours post dose
Part A: Apparent Terminal Half-life (T1/2) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Measured: Up to 36 hours post dose
Part B: AUC (0-t) of Nintedanib
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Measured: Up to 48 hours post dose
Part B: AUC (0-inf) of Nintedanib
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Measured: Up to 48 hours post dose
Part B: Cmax of Nintedanib
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 48 hours post dose
Secondary outcomes (7)
Part B: Number of Participants with AEs
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 17
Part B: Number of Participants with SAEs
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
Measured: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Clinically Laboratory Values
Number of participants with clinically significant changes in vital signs (temperature, systolic and diastolic BP, pulse rate and RR) will be assessed.
Measured: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Measured: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in 12-Lead ECG
Blood sample will be collected to evaluate the time of maximum plasma concentration of Nintedanib.
Measured: Up to Day 17
Part B: Tmax of Nintedanib
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Measured: Up to 48 hours post dose
Part B: T1/2 of Nintedanib
Measured: Up to 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start7 Oct 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625489
- Sponsor's protocol ID
- 222308
- Status last verified
- Feb 2025
- First submitted
- 1 Oct 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3915393 Administered as a Single Dose to Healthy Participants of Chinese, Japanese and European Ancestry, and to Assess the Effects of GSK3915393, on the Pharmacokinetics of Nintedanib
- ClinicalTrials.gov ID
- NCT06625489
- Acronym / sponsor ID
- 222308
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- GSK3915393, Nintedanib, Drug-drug interaction, P-gp inhibitor, Idiopathic pulmonary fibrosis, Interstitial lung disease, Japanese, Chinese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GSK3915393 is a new medicine which is being developed for a chronic lung disease called Idiopathic Pulmonary Fibrosis (IPF). This is a healthy participant study which has two parts. Part A will assess the safety, tolerability, and blood levels of GSK3915393 given as a single dose to healthy participants of Chinese, Japanese, and European ancestries. Part B is a drug-drug interaction (DDI) study that examines the effect of a single dose of GSK3915393 on the blood levels of a single dose of nintedanib, which is an approved drug for IPF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: GSK3915393 | Experimental | Drug: GSK3915393Participants from Chinese, Japanese, and European ancestries will be randomized to receive GSK3915393 under fasting condition. |
| Part A: Placebo | Placebo comparator | Drug: Part A: PlaceboParticipants from Chinese, Japanese, and European ancestries will be randomized to receive placebo under fasting condition. |
| Part B: Nintedanib followed by Nintedanib plus GSK3915393 | Experimental | Drug: Nintedanib, Drug: GSK3915393Male participants will be randomized to receive Nintedanib in Period 1 followed by co-administration of Nintedanib and GSK3915393 in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. |
| Part B: Nintedanib plus GSK3915393 followed by Nintedanib | Experimental | Drug: Nintedanib, Drug: GSK3915393Male participants will be randomized to receive co-administration of Nintedanib and GSK3915393 in Period 1 followed by Nintedanib in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessments, and laboratory tests Body weight at least 50.0 kilograms (kg) (110 pounds [lbs]) for male participants (Part A and Part B) or at least 45.0 kg (99 lbs) for female participants (Part A only) Body mass index (BMI) within the range of 18.0 to 28.0 kilogram per square meter (kg/m^2) (inclusive) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
- Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is a woman of non-childbearing potential (WONCBP) Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method prior to and during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (for example, noncompliance, recently initiated in relationship to the first dose of study intervention) A WOCBP must have a negative highly sensitive pregnancy test within 30 days before the first dose of study intervention Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong or Taiwan; descendant of four ethnic Chinese grandparents and two ethnic Chinese parents; and have lived outside China, Hong Kong or Taiwan for less than 10 years at the time of screening Participants of Japanese ancestry are eligible if born in Japan; Descendant of four ethnic Japanese grandparents and two ethnic Japanese parents; and have lived outside Japan for less than 10 years at the time of screening Participants of European ancestry are eligible if Self-identified as being of European ancestry (i.e. from the original peoples of Europe) irrespective of current place of residence; and descendant of four grandparents and two parents of European ancestry
Key exclusion criteria (1 listed)
- 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 Participants with systolic blood pressure (BP) greater than (>) 140 millimeter of mercury (mmHg) or diastolic BP > 90 mmHg at screening or pulse rate outside the range of 40 to 100 beats per minute (bpm) will be excluded from the study Alanine transaminase (ALT) or aspartate aminotransferase (AST) >1× upper limit of normal (ULN) Total bilirubin >1.5×ULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5×ULN as long as direct bilirubin is less than or equal to (≤) 1.5×ULN Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) QT interval corrected (QTc) >450 milliseconds (msec) at Screening visit based on the average of triplicate ECGs Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, probiotics, antacids, 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) prior to the first dose of study intervention, unless in the opinion of the Investigator and the Medical Monitor, the medication will not interfere with the study procedures or compromise participant safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part A: PlaceboPlacebo will be administered. | Drug | Part A: Placebo |
| NintedanibNintedanib will be administered. | Drug | Part B: Nintedanib followed by Nintedanib plus GSK3915393, Part B: Nintedanib plus GSK3915393 followed by Nintedanib |
| GSK3915393GSK3915393 will be administered. | Drug | Part A: GSK3915393, Part B: Nintedanib followed by Nintedanib plus GSK3915393, Part B: Nintedanib plus GSK3915393 followed by Nintedanib |
Primary outcome
Part A: Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 10
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.
Part A: Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 10
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.
Part A: Number of Participants with Clinically Significant Changes in Clinical Laboratory Values
Time frame: Up to Day 10
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
Part A: Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 10
Number of participants with clinically significant changes in Vital signs (temperature, systolic and diastolic blood pressure [BP], pulse rate and respiratory rate [RR]) will be assessed.
Part A: Number of Participants with Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)
Time frame: Up to Day 10
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Part A: Area Under the Plasma Concentration Versus Time Curve From Time Zero To t (AUC [0-t]) of GSK3915393
Time frame: Up to 36 hours post dose
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Part A: Area Under the Plasma Concentration Versus Time Curve From Time Zero To Infinity (AUC [0-inf]) of GSK3915393
Time frame: Up to 36 hours post dose
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Part A: Maximum Observed Plasma Concentration (Cmax) of GSK3915393
Time frame: Up to 36 hours post dose
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Part A: Time to Cmax (Tmax) of GSK3915393
Time frame: Up to 36 hours post dose
Blood sample will be collected to evaluate time of maximum plasma concentration of GSK3915393.
Part A: Apparent Terminal Half-life (T1/2) of GSK3915393
Time frame: Up to 36 hours post dose
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Part B: AUC (0-t) of Nintedanib
Time frame: Up to 48 hours post dose
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Part B: AUC (0-inf) of Nintedanib
Time frame: Up to 48 hours post dose
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Part B: Cmax of Nintedanib
Time frame: Up to 48 hours post dose
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
7 secondary outcomes
Part B: Number of Participants with AEs
Time frame: Up to Day 17
Part B: Number of Participants with SAEs
Time frame: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Clinically Laboratory Values
Time frame: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in 12-Lead ECG
Time frame: Up to Day 17
Part B: Tmax of Nintedanib
Time frame: Up to 48 hours post dose
Part B: T1/2 of Nintedanib
Time frame: Up to 48 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nintedanib and GSK3915393 in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 2 sites in United States.
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 5 inclusion and 1 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Part A: Number of Participants with Adverse Events (AEs) (time frame: Up to Day 10). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025.