Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LJN452 · 2 trials · 2 indications
Number of patients reported with adverse events , serious adverse events and death.
Stool frequency at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined
Stool Form at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness.
The maximum (peak) observed drug concentration after single dose administration (mass x volume-1)
Time to reach the maximum (peak) plasma drug concentration after single dose administration (time)
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration sampling time (mass x time x volume-1)
The area under the concentration-time curve from time zero to infinity (mass x time x volume-1)
The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve
The apparent total body clearance of the drug from plasma (volume x time-1)
The apparent volume of distribution during the terminal phase
| Arm | Type | Description |
|---|---|---|
| LJN452 followed by placebo | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days. |
| Placebo followed by LJN452 | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days. |
| Group 1 - Normal Hepatic Function | OTHER | Normal hepatic function - Control - control group |
| Group 2 - Mild Hepatic Impairment | EXPERIMENTAL | Mild hepatic impairment - Child-Pugh A (Score 5-6) |
| Group 3 - Moderate Hepatic Impairment | EXPERIMENTAL | Moderate hepatic impairment - Child-Pugh B (Score 7-9) |
| Group 4 - Severe Hepatic Impairment | EXPERIMENTAL | Severe hepatic impairment - Child-Pugh C (score 10-15) |
| Name | Type | Description |
|---|---|---|
| LJN452 | DRUG | Capsules containing LJN452 |
| Placebo to LJN452 | DRUG | Capsules containing placebo to LJN452 |
Key Inclusion Criteria: * A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool frequency of at least 2 per day when off therapy AND Average stool form of \>5 on Bristol Stool Chart. * Previous laboratory or radiological confirmation of bile acid malabsorption with e...
LJN452 is an investigational small molecule being studied for Non-alcoholic Fatty Liver Disease and Primary Bile Acid Diarrhea. It is developed by Novartis AG and is in clinical development, with completed trials in both indications.
LJN452 is developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule in clinical development for gastrointestinal conditions.
LJN452 is in clinical development, with completed trials including a Phase 1 study and a Phase 2 study. It is not approved and remains investigational. The Phase 1 trial evaluated pharmacokinetics in hepatic impairment, and the Phase 2 trial assessed safety and efficacy in Primary Bile Acid Diarrhea.
LJN452 has two completed clinical trials. NCT02713243 was a Phase 2 study in Primary Bile Acid Diarrhea with 20 participants in the United States and United Kingdom. NCT03681457 was a Phase 1 pharmacokinetic study in Non-alcoholic Fatty Liver Disease with 42 participants in the United States.
LJN452 is also known as Tropifexor. The Phase 1 clinical trial NCT03681457 evaluated the pharmacokinetics of Tropifexor in subjects with hepatic impairment, confirming that LJN452 and Tropifexor refer to the same investigational drug.