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

NCT ID: NCT06625489

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2024-11-25

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: GSK3915393

Participants from Chinese, Japanese, and European ancestries will be randomized to receive GSK3915393 under fasting condition.

Group Type: EXPERIMENTAL

GSK3915393

Intervention Type: DRUG

GSK3915393 will be administered.

Part A: Placebo

Participants from Chinese, Japanese, and European ancestries will be randomized to receive placebo under fasting condition.

Group Type: PLACEBO_COMPARATOR

Part A: Placebo

Intervention Type: DRUG

Placebo will be administered.

Part B: Nintedanib followed by Nintedanib plus GSK3915393

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.

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Nintedanib will be administered.

GSK3915393

Intervention Type: DRUG

GSK3915393 will be administered.

Part B: Nintedanib plus GSK3915393 followed by Nintedanib

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.

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Nintedanib will be administered.

GSK3915393

Intervention Type: DRUG

GSK3915393 will be administered.

Interventions

Part A: Placebo

Placebo will be administered.

Intervention Type: DRUG

Nintedanib

Nintedanib will be administered.

Intervention Type: DRUG

GSK3915393

GSK3915393 will be administered.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Cypress, California, United States

GSK Investigational Site

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

222308

Identifier Type: -

Identifier Source: org_study_id