HealthyPhase 1NCT01916850
Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects
A Phase 1 study testing LX4211 400 mg and LX4211 800 mg in people with Healthy, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial 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. 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?
- LX4211 400 mg and LX4211 800 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 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
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 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
Show all 17Show 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 14 days prior to Day 1
- History of alcohol or substance abuse within 2 years prior to Day 1
- Donation or loss of >400 mL of blood or blood product within 3 months of dosing
- Positive urine glucose at Screening
- Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
- Inability or difficulty swallowing pills
- Unable or unwilling to communicate or cooperate with the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Healthy
- Being tested
- LX4211 400 mg, LX4211 800 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
LX4211 800 mgDrug
LX4211 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LX4211 Low Dose | Experimental | 400 mg of LX4211 administered once daily for 10 consecutive days Receives: Drug: LX4211 400 mg |
| LX4211 High Dose | Experimental | 800 mg of LX4211 administered once daily for 10 consecutive days Receives: Drug: LX4211 800 mg |
| Placebo | Placebo comparator | Identical placebo administered once daily for 10 consecutive days Receives: Drug: LX4211 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: Up to Day 10
Secondary outcomes (1)
Area under the curve
Measured: Days 1 through 10
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.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ikenna (Ike) Ogbaa, M.D., Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916850
- Sponsor's protocol ID
- LX4211.1-110-NRM
- Other IDs
- LX4211.110
- Status last verified
- Oct 2013
- First submitted
- 29 Jul 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
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 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
- ClinicalTrials.gov ID
- NCT01916850
- Acronym / sponsor ID
- LX4211.1-110-NRM
- Conditions
- Healthy
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LX4211 Low Dose | Experimental | Drug: LX4211 400 mg400 mg of LX4211 administered once daily for 10 consecutive days |
| LX4211 High Dose | Experimental | Drug: LX4211 800 mg800 mg of LX4211 administered once daily for 10 consecutive days |
| Placebo | Placebo comparator | Drug: LX4211 PlaceboIdentical placebo administered once daily for 10 consecutive days |
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 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
Key exclusion criteria (17 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 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
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 | LX4211 Low Dose |
| LX4211 800 mg | Drug | LX4211 High Dose |
| LX4211 Placebo | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to Day 10
1 secondary outcome
Area under the curve
Time frame: Days 1 through 10
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.
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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.
Ikenna (Ike) Ogbaa, 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 LX4211 800 mg 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 17 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?
Number of Participants with Adverse Events (time frame: Up to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.