The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid diarrhea and to assess its safety and tolerability profile in patients with primary bile acid diarrhea (pBAD) to guide decision-making regarding further clinical development in this indication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Capsules containing LJN452
Capsules containing placebo to LJN452
Novartis Investigative Site
Rochester, Minnesota, United States
Novartis Investigative Site
Harrow, Middlesex, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Sheffield, United Kingdom
Number of Patients Reported With Adverse Events , Serious Adverse Events and Death.
Number of patients reported with adverse events , serious adverse events and death.
Time frame: up to Day 79
Stool Frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Stool frequency at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined
Time frame: 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
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.
Time frame: Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined
Area Under the Plasma Concentration-time Profile (AUCtau) of LJN452
AUCtau- is the area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau \[mass x time / volume\]
Time frame: Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)
(Cmax) of LJN452
Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration \[mass / volume\]
Time frame: Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)
Time to Reach Maximum Concentration After Drug Administration (Tmax)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tmax is the time to reach the maximum concentration after drug administration \[time\]
Time frame: Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)
Total Dose of Rescue Medication Used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined
Total Dose of Rescue Medication used at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined; Rescue Medication used was loperamide
Time frame: Baseline, Week 1 (Period 1 & 2), Week 2 (Period 1 & 2), Week 1 & 2 combined