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

NCT01916850 | Completed Phase 1

• 2 other identifiers: LX4211.1-110-NRMLX4211.110
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  Up to Day 10

Secondary Outcomes (1)

• Area under the curve

  Days 1 through 10

Study Arms (3)

LX4211 Low Dose

EXPERIMENTAL

400 mg of LX4211 administered once daily for 10 consecutive days

Drug: LX4211 400 mg

LX4211 High Dose

EXPERIMENTAL

800 mg of LX4211 administered once daily for 10 consecutive days

Drug: LX4211 800 mg

Placebo

PLACEBO COMPARATOR

Identical placebo administered once daily for 10 consecutive days

Drug: LX4211 Placebo

Interventions

LX4211 400 mg DRUG

LX4211 Low Dose

LX4211 800 mg DRUG

LX4211 High Dose

LX4211 Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

Dallas, Texas, United States

Location

MeSH Terms

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Study Officials

• Ikenna (Ike) Ogbaa, M.D.

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 6, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

US (1)