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Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066

NCT03198767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-01-05

Study results available
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Summary

The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LIK066.

Conditions

Interventions

DRUG

LIK066

LIK066 50 mg tablets. Open-label, bulk, blister-pack.

DIETARY_SUPPLEMENT

Carbohydrate 50%

50% carbohydrate in breakfast meal

DIETARY_SUPPLEMENT

Carbohydrate 25%

25% carbohydrate in breakfast meal

DIETARY_SUPPLEMENT

Carbohydrate 8%

8% carbohydrate in breakfast meal

DIETARY_SUPPLEMENT

Carbohydrate 0%

0% carbohydrate in breakfast meal

DIETARY_SUPPLEMENT

Psyllium

Powder 6 grams

DIETARY_SUPPLEMENT

Calcium carbonate

Liquid 1 gram (4 mL equivalent sugar free)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2017-09-04
Completion
2017-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03198767 on ClinicalTrials.gov