PK Study of Sotagliflozin in Subjects With Hepatic Impairment (NCT02471274) | Clinical Trial Compass
CompletedPhase 1
PK Study of Sotagliflozin in Subjects With Hepatic Impairment
United States32 participantsStarted 2015-06
Plain-language summary
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult male and female subjects ≥18 to ≤70 years of age
* Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening
* Subjects with mild, moderate, or severe hepatic impairment
* Control group of matched healthy subjects
* Willing and able to provide written informed consent
Exclusion Criteria:
* Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
* History of any major surgery within 6 months
* History of renal disease, or significantly abnormal kidney function test
* Women who are breastfeeding or are planning to become pregnant during the study
What they're measuring
1
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters