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To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.

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ClinicalTrials.gov Identifier: NCT02713243
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Bile Acid Diarrhea Drug: LJN452 Drug: Placebo to LJN452 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized Placebo Controlled Crossover Multiple Dose Study of LJN452 to Assess Safety, Tolerability and Efficacy in Patients With Primary Bile Acid Diarrhea (pBAD).
Actual Study Start Date : January 16, 2016
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: LJN452 followed by placebo
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.
Drug: LJN452
Capsules containing LJN452

Drug: Placebo to LJN452
Capsules containing placebo to LJN452

Experimental: Placebo followed by LJN452
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.
Drug: LJN452
Capsules containing LJN452

Drug: Placebo to LJN452
Capsules containing placebo to LJN452




Primary Outcome Measures :
  1. Number of patients reported with adverse events , serious adverse events and death. [ Time Frame: up to Day 79 ]
  2. Change from baseline in stool frequency [ Time Frame: Day 1 Predose, Day 14 of period 1 and period 2 ]
    Clinical symptoms will be measured as change from baseline in stool frequency.

  3. Change from baseline in stool types [ Time Frame: Day 1 Predose, Day 14 of period 1 and period 2 ]
    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.


Secondary Outcome Measures :
  1. Area under the plasma concentration-time profile (AUCtau) of LJN452 [ Time Frame: Day 1 (upto 8 hours), Day 2 (pre-dose) and Day 12 (upto 8 hours) in each treatment period ]
  2. Maximum plasma concentration (Cmax) of LJN452. [ Time Frame: Day 1 (upto 8 hours), Day 2 (pre-dose) and Day 12 (upto 8 hours) in each treatment period ]
  3. Time to reach maximum concentration after durg administration (Tmax) [ Time Frame: Day 1 (upto 8 hours), Day 2 (pre-dose) and Day 12 (upto 8 hours) in each treatment period ]
  4. Total dose of rescue medication used [ Time Frame: upto Day 79 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 either fecal bile acid loss OR 7 day 75Selenium homocholic acid taurine (75SeHCAT) retention.
  • Age ≥ 18 years.

Key Exclusion Criteria:

  • Patients with other diagnoses leading to diarrhea, including colorectal neoplasia, ulcerative colitis, Crohn's disease, celiac disease, chronic pancreatitis, drug-induced diarrhea or active infection AND Patients who have not been investigated by standard clinical assessments to exclude these disorders.
  • Treatment with bile acid sequestrants (colestyramine, colestipol, colesevelam) for 2 weeks before the first dose of LJN452. A washout of 14 days for these agents will be allowed before first dosing.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • A positive Hepatitis B surface antigen or Hepatitis C test result.
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713243


Locations
United States, Minnesota
Novartis Investigative Site
Rochester, Minnesota, United States, 55905
United Kingdom
Novartis Investigative Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Novartis Investigative Site
London, United Kingdom, W2 1PG
Novartis Investigative Site
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Study Director Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02713243     History of Changes
Other Study ID Numbers: CLJN452X2202
2015-003192-30 ( EudraCT Number )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Primary bile acid diarrhea,
FXR agonist,
bile acid malabsorption.

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Bile Acids and Salts
Gastrointestinal Agents