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OpenTrials
Completed

NCT Number: NCT01916850

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LX4211 400 mg

Drug

LX4211 800 mg

Drug

LX4211 Placebo

Drug

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Up to Day 10

Secondary outcomes

  1. Area under the curve

    Time frame: Days 1 through 10

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1b, Single-center, Double-blind, Randomized, Placebo-controlled Study on the Safety, Tolerability, and Pharmacokinetic Effects of Multiple Doses of LX4211 400 mg qd and LX4211 800 mg qd in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
First posted
Aug 6, 2013
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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