Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
NCT ID: NCT03198767
Last Updated: 2021-01-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2017-06-21
2017-09-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
NCT02314936
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
NCT01642914
Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
NCT02228616
A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
NCT01523184
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
NCT01707667
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 50%
50% carbohydrate in breakfast meal
Carbohydrate 25%
25% carbohydrate in breakfast meal
Carbohydrate 0%
0% carbohydrate in breakfast meal
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 50%
50% carbohydrate in breakfast meal
Carbohydrate 25%
25% carbohydrate in breakfast meal
Carbohydrate 0%
0% carbohydrate in breakfast meal
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 50%
50% carbohydrate in breakfast meal
Carbohydrate 25%
25% carbohydrate in breakfast meal
Carbohydrate 0%
0% carbohydrate in breakfast meal
Part A: LIK066 + P1: 8% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 8%
8% carbohydrate in breakfast meal
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 50%
50% carbohydrate in breakfast meal
Psyllium
Powder 6 grams
Calcium carbonate
Liquid 1 gram (4 mL equivalent sugar free)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 50%
50% carbohydrate in breakfast meal
Psyllium
Powder 6 grams
Calcium carbonate
Liquid 1 gram (4 mL equivalent sugar free)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 50%
50% carbohydrate in breakfast meal
Psyllium
Powder 6 grams
Calcium carbonate
Liquid 1 gram (4 mL equivalent sugar free)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Carbohydrate 50%
50% carbohydrate in breakfast meal
Carbohydrate 25%
25% carbohydrate in breakfast meal
Carbohydrate 8%
8% carbohydrate in breakfast meal
Carbohydrate 0%
0% carbohydrate in breakfast meal
Psyllium
Powder 6 grams
Calcium carbonate
Liquid 1 gram (4 mL equivalent sugar free)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Lincoln, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLIK066B2203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.