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Completed

NCT Number: NCT02373046

Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets

This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in healthy subjects under fasted conditions.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

Dallas, Texas, 75247, 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
  • Willing and able to provide written informed consent

Exclusion criteria

  • Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, 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 LX4211
  • History of renal disease, or significantly abnormal kidney function test at Screening
  • History of hepatic disease, or significantly abnormal liver function tests at Screening
  • History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality

Treatment and study plan

LX4211

Drug

Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

Primary outcomes

  1. AUC

    Time frame: Days 1 to 5, Days 9 to 13

  2. Urinary Glucose Excretion (UGE)

    Time frame: Day 1, Day 9

Secondary outcomes

  1. # of Adverse Events

    Time frame: Day 1-Day 14

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Single-center, Open-label, 2-sequence, 2-period, Single-dose Crossover Study to Evaluate Bioequivalence (Pharmacokinetics) and to Compare Total 24-hour Urinary Glucose Excretion (Pharmacodynamics) When 400 mg LX4211 is Administered as a Single 400-mg Tablet and 2 × 200-mg Tablets in Healthy Male and Female Subjects

Important dates

Study start
2015
Primary completion
2015
First posted
Feb 26, 2015
Registry last updated
Oct 2, 2015

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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