Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nintedanib · 1 trial · 1 indication
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 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.
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
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.
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate time of maximum plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Blood sample will be collected to evaluate plasma concentration 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
| Arm | Type | Description |
|---|---|---|
| Part A: GSK3915393 | EXPERIMENTAL | Participants from Chinese, Japanese, and European ancestries will be randomized to receive GSK3915393 under fasting condition. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants from Chinese, Japanese, and European ancestries will be randomized to receive placebo under fasting condition. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Part A: Placebo | DRUG | Placebo will be administered. |
| Nintedanib | DRUG | Nintedanib will be administered. |
| GSK3915393 | DRUG | GSK3915393 will be administered. |
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 pound...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
Nintedanib is a small molecule being studied for Idiopathic Pulmonary Fibrosis (IPF). It is currently in Phase 1 clinical development as an investigational drug. A completed trial evaluated its safety, tolerability, and blood levels when administered to healthy participants of Chinese, Japanese, and European ancestry, with a focus on its effects on IPF.
Nintedanib is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this small molecule for the treatment of Idiopathic Pulmonary Fibrosis.
Nintedanib is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for Idiopathic Pulmonary Fibrosis. One Phase 1 trial has been completed, involving 50 participants.
Nintedanib has one completed clinical trial registered under NCT06625489. This Phase 1 study evaluated the safety, tolerability, and blood levels of GSK3915393 when administered to healthy participants of Chinese, Japanese, and European ancestry, and assessed its effects on Nintedanib. The trial was conducted in the United States.
Nintedanib is the drug being studied, while GSK3915393 appears to be a related compound investigated in the same clinical trial. The completed Phase 1 study (NCT06625489) evaluated the safety, tolerability, and blood levels of GSK3915393 and assessed its effects on Nintedanib in healthy participants.