Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Single-center, Partially Double-blind, Randomized, Single-dose, 3-Period Crossover Study to Assess the Pharmacodynamic Effects of LX4211 and INVOKANA™ (Canagliflozin) in Healthy Subjects Using Stable Isotope Tracer Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916863
• Other study ID #: LX4211.1-111-NRM
• Secondary ID: LX4211.111
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2013
• Last updated: October 28, 2013
• Start date: August 2013

Study information

• Verified date: October 2013
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 =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 7 days of dosing

• Use of any investigational agent or study treatment within 30 days of Day -1

• Use of any protein or antibody-based therapeutic agents within 3 months of Screening

• Prior exposure to LX4211 or canagliflozin

• Daily use of >5 cigarettes or any tobacco products within 6 weeks prior to Screening and while participating in the study

• History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption

• History of bowel resection, any malabsorptive disorder, severe gastroparesis, any GI procedure for the purpose of weight loss which would slow gastric emptying

• History of any major surgery within 6 months prior to Screening

• History of any hypersensitivity to the inactive components of LX4211, inactive components of canagliflozin, acetaminophen oral solution or any inactive component of acetaminophen liquid preparation

• 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 30 days prior to Day -1

• History of alcohol or substance abuse within 2 years prior to Day 1

• History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2

• Donation or loss of >500 mL of blood or blood product within 56 days of Day -1

• positive pregnancy test at Screening or Day -1

• Positive urine screen for drugs of abuse at Screening or Day -1

• Positive breath test for alcohol at Screening or Day -1

• Inability or difficulty swallowing whole tablets

• Unable or unwilling to communicate or cooperate with the Investigator

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• LX4211 400 mg

• canagliflozin 300 mg

• LX4211 Placebo

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in rate of glucose appearance after meal (RaO)		Days 1, 8, 15	No
Secondary	Rate of total glucose appearance (RaT)		Days 1, 8, 15	No
Secondary	Change from baseline in fasting plasma glucose		Days 1, 8, 15	No
Secondary	Change from baseline in postprandial glucose		Days 1, 8, 15	No
Secondary	Change from baseline in insulin		Days 1, 8, 15	No