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DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin

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ClinicalTrials.gov Identifier: NCT02300363
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment A (rosuvastatin) Drug: Treatment B (LX4211) Drug: Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A
10 mg oral rosuvastatin administration
Drug: Treatment A (rosuvastatin)
10 mg rosuvastatin administered on Day 1 and Day 13

Experimental: Treatment B
400 mg oral LX4211 qd administration
Drug: Treatment B (LX4211)
400 mg LX4211 administered on Day 7 through Day 13

Experimental: Treatment C
10 mg oral rosuvastatin administration + 400 mg oral LX4211 qd administration
Drug: Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly)
10 mg rosuvastatin + 400 mg LX4211 administered concomitantly on Day 13




Primary Outcome Measures :
  1. AUC [ Time Frame: Day 1-Day 5, Day 13-Day 17 ]

Secondary Outcome Measures :
  1. # of Adverse Events [ Time Frame: Day 1-Day 17 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300363


Locations
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United States, Indiana
Lexicon Investigational Site
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02300363     History of Changes
Other Study ID Numbers: LX4211.1-115-NRM
LX4211.115 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs