A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01916850

Healthy

COMPLETED PHASE1

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects

NCT03869320

Healthy

COMPLETED PHASE1

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects

NCT01883544

Healthy Subjects

COMPLETED PHASE1

Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

NCT03531229

Healthy

COMPLETED PHASE1

LEO 32731 - A Study in Healthy Male Subjects

NCT01310049

Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LX4211

400 mg of LX4211 administered orally

Group Type EXPERIMENTAL

Schedule A

Intervention Type DRUG

Dosing 1 hour before breakfast

Schedule B

Intervention Type DRUG

Dosing 0.5 hour before breakfast

Schedule C

Intervention Type DRUG

Dosing immediately before breakfast

Schedule D

Intervention Type DRUG

Dosing immediately before lunch

Schedule E

Intervention Type DRUG

Split dose, dosing 1 hour before breakfast and dinner

Placebo

Nonidentical placebo administered orally

Group Type PLACEBO_COMPARATOR

Schedule A

Intervention Type DRUG

Dosing 1 hour before breakfast

Schedule B

Intervention Type DRUG

Dosing 0.5 hour before breakfast

Schedule C

Intervention Type DRUG

Dosing immediately before breakfast

Schedule D

Intervention Type DRUG

Dosing immediately before lunch

Schedule E

Intervention Type DRUG

Split dose, dosing 1 hour before breakfast and dinner

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Schedule A

Dosing 1 hour before breakfast

Intervention Type DRUG

Schedule B

Dosing 0.5 hour before breakfast

Intervention Type DRUG

Schedule C

Dosing immediately before breakfast

Intervention Type DRUG

Schedule D

Dosing immediately before lunch

Intervention Type DRUG

Schedule E

Split dose, dosing 1 hour before breakfast and dinner

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults ≥18 and ≤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
* 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 Day 1
* Use of any protein or antibody-based therapeutic agents within 3 months of Screening
* Prior exposure to any SGLT inhibitor
* Use of 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 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 30 days of Day 1
* History of alcohol or substance abuse within 2 years prior to Day 1
* Positive urine glucose at Screening
* Positive pregnancy test at Screening
* Inability or difficulty swallowing whole tablets or capsules
* Unable or unwilling to communicate or cooperate with the Investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes