Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LX4211 800 mg; Drug: LX4211 Placebo; Drug: LX4211 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01916850

LX4211.1-110-NRM

LX4211.110 (Other Identifier)

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.

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 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 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 5 days of dosing
• Use of any investigational agent or study treatment within 30 days of dosing
• Use of any protein or antibody-based therapeutic agents within 3 months of Screening
• Prior exposure to LX4211
• Use of cigarettes or any tobacco products within 2 months 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 14 days prior to Day 1
• History of alcohol or substance abuse within 2 years prior to Day 1
• Donation or loss of >400 mL of blood or blood product within 3 months of dosing
• Positive urine glucose at Screening
• Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
• Inability or difficulty swallowing pills
• 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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25 participants in 3 patient groups, including a placebo group

LX4211 Low Dose

Experimental group

Description:

400 mg of LX4211 administered once daily for 10 consecutive days

Treatment:

Drug: LX4211 400 mg

LX4211 High Dose

Experimental group

Description:

800 mg of LX4211 administered once daily for 10 consecutive days

Treatment:

Drug: LX4211 800 mg

Placebo

Placebo Comparator group

Description:

Identical placebo administered once daily for 10 consecutive days

Treatment:

Drug: LX4211 Placebo