NCT01916850
Completed
Phase 1
A Phase 1b, Single-center, Double-blind, Randomized, Placebo-controlled Study on the Safety, Tolerability, and Pharmacokinetic Effects of Multiple Doses of LX4211 400 mg qd and LX4211 800 mg qd in Healthy Subjects
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- LX4211 400 mg
- Conditions
- Healthy
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
LX4211 Low Dose
400 mg of LX4211 administered once daily for 10 consecutive days
Intervention: LX4211 400 mg
LX4211 High Dose
800 mg of LX4211 administered once daily for 10 consecutive days
Intervention: LX4211 800 mg
Placebo
Identical placebo administered once daily for 10 consecutive days
Intervention: LX4211 Placebo
Outcomes
Primary Outcomes
Number of Participants with Adverse Events
Time Frame: Up to Day 10
Secondary Outcomes
- Area under the curve(Days 1 through 10)
Study Sites (1)
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