Last updated: 02/14/2025 12:50:07
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
GSK study ID
222308
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Part A: Number of Participants with Adverse Events (AEs)
Timeframe: Up to Day 10
Part A: Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in Clinical Laboratory Values
Timeframe: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)
Timeframe: Up to Day 10
Part A: Area Under the Plasma Concentration Versus Time Curve From Time Zero To t (AUC [0-t]) of GSK3915393
Timeframe: 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
Timeframe: Up to 36 hours post dose
Part A: Maximum Observed Plasma Concentration (Cmax) of GSK3915393
Timeframe: Up to 36 hours post dose
Part A: Time to Cmax (Tmax) of GSK3915393
Timeframe: Up to 36 hours post dose
Part A: Apparent Terminal Half-life (T1/2) of GSK3915393
Timeframe: Up to 36 hours post dose
Part B: AUC (0-t) of Nintedanib
Timeframe: Up to 48 hours post dose
Part B: AUC (0-inf) of Nintedanib
Timeframe: Up to 48 hours post dose
Part B: Cmax of Nintedanib
Timeframe: Up to 48 hours post dose
Secondary outcomes:
Part B: Number of Participants with AEs
Timeframe: Up to Day 17
Part B: Number of Participants with SAEs
Timeframe: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Clinically Laboratory Values
Timeframe: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in 12-Lead ECG
Timeframe: Up to Day 17
Part B: Tmax of Nintedanib
Timeframe: Up to 48 hours post dose
Part B: T1/2 of Nintedanib
Timeframe: Up to 48 hours post dose
Interventions:
Drug: Part A: Placebo
Drug: Nintedanib
Drug: GSK3915393
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2024-25-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Idiopathic Pulmonary Fibrosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2024 to November 2024
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 Years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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 location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2024-25-11
Actual study completion date
2024-25-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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