HealthyPhase 1NCT01334242
A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
A Phase 1 study testing Schedule A, Schedule B and Schedule C in people with Healthy, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Schedule A, Schedule B and Schedule C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexicon Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.
- Conditions
- Healthy
- Being tested
- Schedule A, Schedule B, Schedule C, Schedule D, Schedule E
- Keywords
- Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schedule ADrug
Dosing 1 hour before breakfast
Schedule BDrug
Dosing 0.5 hour before breakfast
Schedule CDrug
Dosing immediately before breakfast
Schedule DDrug
Dosing immediately before lunch
Schedule EDrug
Split dose, dosing 1 hour before breakfast and dinner
| Study group | Role | What they receive |
|---|---|---|
| LX4211 | Experimental | 400 mg of LX4211 administered orally Receives: Drug: Schedule A; Drug: Schedule B; Drug: Schedule C; Drug: Schedule D; Drug: Schedule E |
| Placebo | Placebo comparator | Nonidentical placebo administered orally Receives: Drug: Schedule A; Drug: Schedule B; Drug: Schedule C; Drug: Schedule D; Drug: Schedule E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary glucose excretion
Measured: 24 hours collection on Day -1 and Days 7-13
Fasting Plasma Glucose
Measured: Day -1 and Days 7-12
Postprandial Glucose
Measured: Day -1 and Days 7-12
Insulin
Measured: Day -1 and Days 7-12
Glucagon-like peptide 1 (total and active)
Measured: Day -1 and Days 7-12
Peptide YY
Measured: Day -1 and Days 7-12
Secondary outcomes (3)
Number of Participants with Adverse Events
Measured: Day 1 to Day 14
Blood chemistry
Including albumin, ALP, ALT, AST, total bilirubin, glucose, BUN, calcium, carbon dioxide, chloride, cholesterol and triglycerides, creatinine, magnesium, phosphorus, potassium, sodium, protein, and uric acid.
Measured: Day -2, Day 7 and Day 13
Hematology
Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.
Measured: Day -2, Day 7 and Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ikenna Ogbaa, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334242
- Sponsor's protocol ID
- LX4211.1-104-NRM
- Other IDs
- LX4211.104
- Status last verified
- May 2011
- First submitted
- 6 Apr 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Zambrowicz B, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Boehm KA, Ruff D, Powell D, Sands A. Effects of LX4211, a dual sodium-dependent glucose cotransporters 1 and 2 inhibitor, on postprandial glucose, insulin, glucagon-like peptide 1, and peptide tyrosine tyrosine in a dose-timing study in healthy subjects. Clin Ther. 2013 Aug;35(8):1162-1173.e8. doi: 10.1016/j.clinthera.2013.06.011. Epub 2013 Jul 31.
PubMed 23911260
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01334242
- Acronym / sponsor ID
- LX4211.1-104-NRM
- Conditions
- Healthy
- Keywords
- Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LX4211 | Experimental | Drug: Schedule A, Drug: Schedule B, Drug: Schedule C, Drug: Schedule D, Drug: Schedule E400 mg of LX4211 administered orally |
| Placebo | Placebo comparator | Drug: Schedule A, Drug: Schedule B, Drug: Schedule C, Drug: Schedule D, Drug: Schedule ENonidentical placebo administered orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schedule ADosing 1 hour before breakfast | Drug | LX4211, Placebo |
| Schedule BDosing 0.5 hour before breakfast | Drug | LX4211, Placebo |
| Schedule CDosing immediately before breakfast | Drug | LX4211, Placebo |
| Schedule DDosing immediately before lunch | Drug | LX4211, Placebo |
| Schedule ESplit dose, dosing 1 hour before breakfast and dinner | Drug | LX4211, Placebo |
Primary outcome
Urinary glucose excretion
Time frame: 24 hours collection on Day -1 and Days 7-13
Fasting Plasma Glucose
Time frame: Day -1 and Days 7-12
Postprandial Glucose
Time frame: Day -1 and Days 7-12
Insulin
Time frame: Day -1 and Days 7-12
Glucagon-like peptide 1 (total and active)
Time frame: Day -1 and Days 7-12
Peptide YY
Time frame: Day -1 and Days 7-12
3 secondary outcomes
Number of Participants with Adverse Events
Time frame: Day 1 to Day 14
Blood chemistry
Time frame: Day -2, Day 7 and Day 13
Hematology
Time frame: Day -2, Day 7 and Day 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Derived from this study: PubMed 23911260Zambrowicz B, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Boehm KA, Ruff D, Powell D, Sands A. Effects of LX4211, a dual sodium-dependent glucose cotransporters 1 and 2 inhibitor, on postprandial glucose, insulin, glucagon-like peptide 1, and peptide tyrosine tyrosine in a dose-timing study in healthy subjects. Clin Ther. 2013 Aug;35(8):1162-1173.e8. doi: 10.1016/j.clinthera.2013.06.011. Epub 2013 Jul 31.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ikenna Ogbaa, MD study director
Lexicon Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Schedule A, Schedule B and Schedule C in people with Healthy, run by Lexicon Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary glucose excretion (time frame: 24 hours collection on Day -1 and Days 7-13). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.