Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: LX4211 Placebo; Drug: canagliflozin 300 mg; Drug: LX4211 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01916863

LX4211.111 (Other Identifier)

LX4211.1-111-NRM

Details and patient eligibility

About

The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult subjects ≥18 to ≤55 years of age
• Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
• Body mass index (BMI) ≥18 and ≤35 kg/sq m
• Willing and able to provide written informed consent

Exclusion criteria

• Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 7 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 LX4211 or canagliflozin
• Daily use of >5 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 bowel resection, any malabsorptive disorder, severe gastroparesis, any GI procedure for the purpose of weight loss which would slow gastric emptying
• History of any major surgery within 6 months prior to Screening
• History of any hypersensitivity to the inactive components of LX4211, inactive components of canagliflozin, acetaminophen oral solution or any inactive component of acetaminophen liquid preparation
• 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 prior to Day -1
• History of alcohol or substance abuse within 2 years prior to Day 1
• History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
• Donation or loss of >500 mL of blood or blood product within 56 days of Day -1
• positive pregnancy test at Screening or Day -1
• Positive urine screen for drugs of abuse at Screening or Day -1
• Positive breath test for alcohol at Screening or Day -1
• Inability or difficulty swallowing whole tablets
• Unable or unwilling to communicate or cooperate with the Investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups, including a placebo group

LX4211

Experimental group

Description:

400 mg of LX4211

Treatment:

Drug: LX4211 Placebo

Drug: LX4211 400 mg

Drug: canagliflozin 300 mg

Canagliflozin

Active Comparator group

Description:

300 mg canagliflozin

Treatment:

Drug: LX4211 Placebo

Drug: LX4211 400 mg

Drug: canagliflozin 300 mg

Placebo

Placebo Comparator group

Description:

LX4211 placebo

Treatment:

Drug: LX4211 Placebo

Drug: LX4211 400 mg

Drug: canagliflozin 300 mg