HealthyPhase 1NCT02300350
DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
A Phase 1 study testing Treatment A digoxin, Treatment B LX4211 and Treatment C Digoxin + 400 mg LX4211 administered concomitantly in people with Healthy, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female 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?
- Treatment A digoxin, Treatment B LX4211 and Treatment C Digoxin + 400 mg LX4211 administered concomitantly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2014
- 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 ≤32 kg/sq m
- Willing and able to provide written informed consent
Who cannot join
- Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
- History of clinically significant arrhythmias
- History of cardiac arrhythmias or palpitations associated with presyncope, syncope, or a family history of sudden cardiac death
- Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study
- Receipt of any investigational agent or study drug within 30 days prior to Screening
- Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening
Show all 24Show fewer
- Prior exposure to LX4211
- Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
- History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or digoxin
- Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or digoxin
- History of any major surgery within 6 months or anticipated surgery prior to Day 1
- History of any clinically significant hypoglycemia or hyperglycemia
- History of renal disease, or significantly abnormal kidney function test at Screening
- History of hepatic disease, or significantly abnormal liver function tests at Screening
- History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
- History of any active infection within 14 days prior to Day 1
- History of alcohol or substance abuse within 2 years prior to Screening
- Positive hepatitis panel
- Donation or loss of >500 mL of blood or blood product within 3 months prior to Screening
- Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test
- Positive urine glucose at Screening
- Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13
- Inability or difficulty swallowing whole tablets
- Unable or unwilling to cooperate with the Investigator for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-center, Open-label, Two-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Digoxin (Lanoxin®), a Sensitive P-glycoprotein (P-gp) Substrate, in Healthy Male and Female Subjects
This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female subjects.
- Conditions
- Healthy
- Being tested
- Treatment A digoxin, Treatment B LX4211, Treatment C Digoxin + 400 mg LX4211 administered concomitantly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A digoxinDrug
0.5 mg digoxin administered on Day 1 and Day 20
Treatment B LX4211Drug
400 mg LX4211 administered daily on Day 14 through Day 25
Treatment C Digoxin + 400 mg LX4211 administered concomitantlyDrug
0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 0.5 mg single-dose oral digoxin administration Receives: Drug: Treatment A digoxin |
| Treatment B | Experimental | 400 mg oral LX4211 qd administration Receives: Drug: Treatment B LX4211 |
| Treatment C | Experimental | 0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration Receives: Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: Day 1-Day 7, Day 20-26
Secondary outcomes (1)
Adverse Events
Measured: Day 1-Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suman Wason, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300350
- Sponsor's protocol ID
- LX4211.1-114-NRM
- Other IDs
- LX4211.114
- Status last verified
- Jul 2015
- First submitted
- 20 Nov 2014
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label, Two-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Digoxin (Lanoxin®), a Sensitive P-glycoprotein (P-gp) Substrate, in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02300350
- Acronym / sponsor ID
- LX4211.1-114-NRM
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Nov 2014 (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 study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Treatment A digoxin0.5 mg single-dose oral digoxin administration |
| Treatment B | Experimental | Drug: Treatment B LX4211400 mg oral LX4211 qd administration |
| Treatment C | Experimental | Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration |
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 ≤32 kg/sq m
- Willing and able to provide written informed consent
Key exclusion criteria (24 listed)
- Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
- History of clinically significant arrhythmias
- History of cardiac arrhythmias or palpitations associated with presyncope, syncope, or a family history of sudden cardiac death
- Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study
- Receipt of any investigational agent or study drug within 30 days prior to Screening
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 |
|---|---|---|
| Treatment A digoxin0.5 mg digoxin administered on Day 1 and Day 20 | Drug | Treatment A |
| Treatment B LX4211400 mg LX4211 administered daily on Day 14 through Day 25 | Drug | Treatment B |
| Treatment C Digoxin + 400 mg LX4211 administered concomitantly0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20 | Drug | Treatment C |
Primary outcome
AUC
Time frame: Day 1-Day 7, Day 20-26
1 secondary outcome
Adverse Events
Time frame: Day 1-Day 26
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 9 Jul 2015.
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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.
Suman Wason, 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 Treatment A digoxin, Treatment B LX4211 and Treatment C Digoxin + 400 mg LX4211 administered concomitantly 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 24 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 9 Jul 2015. 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. 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?
AUC (time frame: Day 1-Day 7, Day 20-26). 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 9 Jul 2015.