Healthy SubjectsPhase 1NCT01916863
Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects
A Phase 1 study testing LX4211 400 mg and canagliflozin 300 mg in people with Healthy Subjects, run by Lexicon Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- LX4211 400 mg and canagliflozin 300 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2013
- 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
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexicon Investigational Site
Chula Vista, California, 91911
About this study
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
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.
- Conditions
- Healthy Subjects
- Being tested
- LX4211 400 mg, canagliflozin 300 mg, LX4211 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX4211 400 mgDrug
canagliflozin 300 mgDrug
LX4211 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LX4211 | Experimental | 400 mg of LX4211 Receives: Drug: LX4211 400 mg; Drug: canagliflozin 300 mg; Drug: LX4211 Placebo |
| Canagliflozin | Active comparator | 300 mg canagliflozin Receives: Drug: LX4211 400 mg; Drug: canagliflozin 300 mg; Drug: LX4211 Placebo |
| Placebo | Placebo comparator | LX4211 placebo Receives: Drug: LX4211 400 mg; Drug: canagliflozin 300 mg; Drug: LX4211 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in rate of glucose appearance after meal (RaO)
Measured: Days 1, 8, 15
Secondary outcomes (4)
Rate of total glucose appearance (RaT)
Measured: Days 1, 8, 15
Change from baseline in fasting plasma glucose
Measured: Days 1, 8, 15
Change from baseline in postprandial glucose
Measured: Days 1, 8, 15
Change from baseline in insulin
Measured: Days 1, 8, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013
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 Healthy SubjectsStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Strumph, M.D., Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916863
- Sponsor's protocol ID
- LX4211.1-111-NRM
- Other IDs
- LX4211.111
- Status last verified
- Oct 2013
- First submitted
- 29 Jul 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
Publications
Powell DR, Zambrowicz B, Morrow L, Beysen C, Hompesch M, Turner S, Hellerstein M, Banks P, Strumph P, Lapuerta P. Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1235-49. doi: 10.1210/clinem/dgz258.
PubMed 31837264
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01916863
- Acronym / sponsor ID
- LX4211.1-111-NRM
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 6 Aug 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LX4211 | Experimental | Drug: LX4211 400 mg, Drug: canagliflozin 300 mg, Drug: LX4211 Placebo400 mg of LX4211 |
| Canagliflozin | Active comparator | Drug: LX4211 400 mg, Drug: canagliflozin 300 mg, Drug: LX4211 Placebo300 mg canagliflozin |
| Placebo | Placebo comparator | Drug: LX4211 400 mg, Drug: canagliflozin 300 mg, Drug: LX4211 PlaceboLX4211 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| LX4211 400 mg | Drug | Canagliflozin, LX4211, Placebo |
| canagliflozin 300 mg | Drug | Canagliflozin, LX4211, Placebo |
| LX4211 Placebo | Drug | Canagliflozin, LX4211, Placebo |
Primary outcome
Change from baseline in rate of glucose appearance after meal (RaO)
Time frame: Days 1, 8, 15
4 secondary outcomes
Rate of total glucose appearance (RaT)
Time frame: Days 1, 8, 15
Change from baseline in fasting plasma glucose
Time frame: Days 1, 8, 15
Change from baseline in postprandial glucose
Time frame: Days 1, 8, 15
Change from baseline in insulin
Time frame: Days 1, 8, 15
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 30 Oct 2013.
- Derived from this study: PubMed 31837264Powell DR, Zambrowicz B, Morrow L, Beysen C, Hompesch M, Turner S, Hellerstein M, Banks P, Strumph P, Lapuerta P. Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1235-49. doi: 10.1210/clinem/dgz258.
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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.
Paul Strumph, M.D. 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 LX4211 400 mg and canagliflozin 300 mg in people with Healthy Subjects, 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 20 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 30 Oct 2013. 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?
Change from baseline in rate of glucose appearance after meal (RaO) (time frame: Days 1, 8, 15). 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 NCT01916863, 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 30 Oct 2013.