A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Schedule A; Drug: Schedule C; Drug: Schedule D; Drug: Schedule B; Drug: Schedule E

Study type: Interventional

Funder types: Industry

Identifiers

NCT01334242

LX4211.1-104-NRM

LX4211.104 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥18 and ≤55 years of age
• Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
• Body mass index (BMI) ≥18 and ≤35 kg/sq m
• Able to provide written informed consent

Exclusion criteria

• Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
• Use of any investigational agent or study treatment within 30 days of Day 1
• Use of any protein or antibody-based therapeutic agents within 3 months of Screening
• Prior exposure to any SGLT inhibitor
• Use of cigarettes or any tobacco products within 6 weeks prior to Screening and while participating in the study
• History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
• History of any major surgery within 6 months of Screening
• History of any hypersensitivity to the inactive components of LX4211
• History of renal disease or significantly abnormal kidney function tests
• History of hepatic disease or significantly abnormal liver function tests
• History of any active infection within 30 days of Day 1
• History of alcohol or substance abuse within 2 years prior to Day 1
• Positive urine glucose at Screening
• Positive pregnancy test at Screening
• Inability or difficulty swallowing whole tablets or capsules
• Unable or unwilling to communicate or cooperate with the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

LX4211

Experimental group

Description:

400 mg of LX4211 administered orally

Treatment:

Drug: Schedule B

Drug: Schedule A

Drug: Schedule E

Drug: Schedule D

Drug: Schedule C

Placebo

Placebo Comparator group

Description:

Nonidentical placebo administered orally

Treatment:

Drug: Schedule B

Drug: Schedule A

Drug: Schedule E

Drug: Schedule D

Drug: Schedule C