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Completed

NCT Number: NCT02300363

DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin

This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male and female 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

Evansville, Indiana, 47710, 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 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
  • Body mass index (BMI) ≥18 and ≤32 kg/sq m
  • 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
  • Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study
  • Receipt of any investigational agent or study drug within 30 days prior to Screening
  • Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening
  • Prior exposure to LX4211
  • Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
  • History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or rosuvastatin
  • Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or rosuvastatin
  • History of any major surgery within 6 months or anticipated surgery prior to Day
  • History of any clinically significant hypoglycemia or hyperglycemia
  • 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
  • History of any active infection within 14 days prior to Day 1
  • History of alcohol or substance abuse within 2 years prior to Screening
  • Positive hepatitis panel
  • Donation or loss of >500 mL of blood or blood product within 3 months prior to Screening
  • Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test
  • Positive urine glucose at Screening
  • Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13
  • Inability or difficulty swallowing whole tablets
  • Unable or unwilling to cooperate with the Investigator for any reason

Treatment and study plan

Treatment A (rosuvastatin)

Drug

10 mg rosuvastatin administered on Day 1 and Day 13

Treatment B (LX4211)

Drug

400 mg LX4211 administered on Day 7 through Day 13

Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly)

Drug

10 mg rosuvastatin + 400 mg LX4211 administered concomitantly on Day 13

Primary outcomes

  1. AUC

    Time frame: Day 1-Day 5, Day 13-Day 17

Secondary outcomes

  1. # of Adverse Events

    Time frame: Day 1-Day 17

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Single-center, Open-label, 2-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Rosuvastatin (Crestor®), a Sensitive Breast Cancer Resistance Protein (BCRP) Substrate, in Healthy Male and Female Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2014
Registry last updated
Jul 9, 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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