HealthyPhase 1NCT01913002
Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy Subjects
A Phase 1 study testing LX4211 800 mg, LX4211 2000 mg and moxifloxacin 400 mg in people with Healthy, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000 mg) do not differ from placebo in the mean change in QTcI from Baseline 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 800 mg, LX4211 2000 mg and moxifloxacin 400 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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
- Able and willing to provide written informed consent
- Nonsmoker and has not used any tobacco products for at least 3 months prior to Screening
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Able to tolerate prolonged periods of quiet, motionless, supervised rest
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 prior to Screening
- Use of any protein or antibody-based therapeutic agents within 3 months prior to Screening
- Prior exposure to LX4211
- Daily use of cigarettes or any tobacco products within 3 months prior to Screening and while participating in the study
- History of any major surgery within 6 months prior to Screening
Show all 25Show fewer
- History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211
- History of renal disease or significantly abnormal kidney function tests
- History of hepatic disease or significantly abnormal liver function tests
- Women who are breastfeeding or are planning to become pregnant during the study
- History of any active infection within 14 days prior to Screening
- History of alcohol or substance abuse within 2 years prior to Screening
- History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
- Presence of clinically significant physical, laboratory, or ECG findings (eg, QTcF >450 msec for females and QTcF >430 msec for males) at Screening
- >30 premature ventricular beats per hour on the telemetry ECG monitoring at Day -2 of Period 1
- History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)
- Any skin condition likely to interfere with ECG electrode placement or adhesion
- Any skin condition likely to interfere with ECG electrode placement or adhesion
- Donation or loss of >400 mL of blood or blood product within 3 months prior to Screening
- Positive urine glucose during Screening
- Positive pregnancy test during Screening
- Positive urine screen for drugs of abuse during Screening
- Positive urine test for alcohol during Screening
- Inability or difficulty swallowing whole tablets or capsules
- Unable or unwilling to communicate or cooperate with the Investigator for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Positive-controlled, 4-period, 4-way Crossover Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 800 mg and 2000 mg Compared With Placebo and Open-label Moxifloxacin in Healthy Subjects: A Thorough QT Study
This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000 mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.
- Conditions
- Healthy
- Being tested
- LX4211 800 mg, LX4211 2000 mg, moxifloxacin 400 mg, LX4211 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX4211 800 mgDrug
LX4211 2000 mgDrug
moxifloxacin 400 mgDrug
LX4211 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | LX4211 800 mg Receives: Drug: LX4211 800 mg; Drug: LX4211 2000 mg; Drug: moxifloxacin 400 mg; Drug: LX4211 Placebo |
| Treatment B | Experimental | LX4211 2000 mg Receives: Drug: LX4211 800 mg; Drug: LX4211 2000 mg; Drug: moxifloxacin 400 mg; Drug: LX4211 Placebo |
| Treatment C | Active comparator | moxifloxacin 400 mg Receives: Drug: LX4211 800 mg; Drug: LX4211 2000 mg; Drug: moxifloxacin 400 mg; Drug: LX4211 Placebo |
| Treatment D | Placebo comparator | Placebo Receives: Drug: LX4211 800 mg; Drug: LX4211 2000 mg; Drug: moxifloxacin 400 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 QTc intervals
Measured: Day -1, Day 1 of each period (2, 3, 4)
Secondary outcomes (2)
Number of subjects experiencing an adverse event
Measured: up to 87 days
Plasma concentrations of LX4211
Measured: Day 1 of each Period: predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 60 hours after dosing time on Day 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 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
- NCT01913002
- Sponsor's protocol ID
- LX4211.1-109-NRM
- Other IDs
- LX4211.109
- Status last verified
- Oct 2013
- First submitted
- 29 Jul 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- 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
- Randomized, Double-blind, Placebo-controlled, Positive-controlled, 4-period, 4-way Crossover Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 800 mg and 2000 mg Compared With Placebo and Open-label Moxifloxacin in Healthy Subjects: A Thorough QT Study
- ClinicalTrials.gov ID
- NCT01913002
- Acronym / sponsor ID
- LX4211.1-109-NRM
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 31 Jul 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.
This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000 mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: LX4211 800 mg, Drug: LX4211 2000 mg, Drug: moxifloxacin 400 mg, Drug: LX4211 PlaceboLX4211 800 mg |
| Treatment B | Experimental | Drug: LX4211 800 mg, Drug: LX4211 2000 mg, Drug: moxifloxacin 400 mg, Drug: LX4211 PlaceboLX4211 2000 mg |
| Treatment C | Active comparator | Drug: LX4211 800 mg, Drug: LX4211 2000 mg, Drug: moxifloxacin 400 mg, Drug: LX4211 Placebomoxifloxacin 400 mg |
| Treatment D | Placebo comparator | Drug: LX4211 800 mg, Drug: LX4211 2000 mg, Drug: moxifloxacin 400 mg, Drug: LX4211 PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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
- Able and willing to provide written informed consent
- Nonsmoker and has not used any tobacco products for at least 3 months prior to Screening
Key exclusion criteria (25 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 prior to Screening
- Use of any protein or antibody-based therapeutic agents within 3 months prior to Screening
- Prior exposure to LX4211
- Daily use of cigarettes or any tobacco products within 3 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 800 mg | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| LX4211 2000 mg | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| moxifloxacin 400 mg | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| LX4211 Placebo | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Change from baseline in QTc intervals
Time frame: Day -1, Day 1 of each period (2, 3, 4)
2 secondary outcomes
Number of subjects experiencing an adverse event
Time frame: up to 87 days
Plasma concentrations of LX4211
Time frame: Day 1 of each Period: predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 60 hours after dosing time on Day 1 hours
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 800 mg, LX4211 2000 mg and moxifloxacin 400 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 7 inclusion and 25 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 QTc intervals (time frame: Day -1, Day 1 of each period (2, 3, 4)). 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.