Hepatic ImpairmentPhase 1NCT02471274
PK Study of Sotagliflozin in Subjects With Hepatic Impairment
A Phase 1 study testing sotagliflozin in people with Hepatic Impairment and Healthy, run by Lexicon Pharmaceuticals at 4 sites in United States.
Trial summary
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy
- What is being tested?
- sotagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2015to Dec 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male and female subjects ≥18 to ≤70 years of age
- Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening
- Subjects with mild, moderate, or severe hepatic impairment
- Control group of matched healthy subjects
- Willing and able to provide written informed consent
Who cannot join
- Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
- Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
- History of any major surgery within 6 months
- History of renal disease, or significantly abnormal kidney function test
- Women who are breastfeeding or are planning to become pregnant during the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lexicon Investigational Site
Lakewood, Colorado, 80228
Lexicon Investigational Site
Miami, Florida, 33014
Lexicon Investigational Site
Minneapolis, Minnesota, 55404
Lexicon Investigational Site
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- sotagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sotagliflozinDrug
single 400 mg dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | healthy control subjects with normal hepatic function Receives: Drug: sotagliflozin |
| Group 2 | Experimental | subjects with mild hepatic impairment Receives: Drug: sotagliflozin |
| Group 3 | Experimental | subjects with moderate hepatic impairment Receives: Drug: sotagliflozin |
| Group 4 | Experimental | subjects with severe hepatic impairment Receives: Drug: sotagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
Measured: Day 1 to Day 5
Secondary outcomes (1)
Number of treatment emergent adverse events
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT02471274
- Sponsor's protocol ID
- LX4211.1-116-HEP
- Other IDs
- LX4211.116
- Status last verified
- Nov 2016
- First submitted
- 11 Jun 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT02471274
- Acronym / sponsor ID
- LX4211.1-116-HEP
- Conditions
- Hepatic Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 15 Jun 2015 (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.
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: sotagliflozinhealthy control subjects with normal hepatic function |
| Group 2 | Experimental | Drug: sotagliflozinsubjects with mild hepatic impairment |
| Group 3 | Experimental | Drug: sotagliflozinsubjects with moderate hepatic impairment |
| Group 4 | Experimental | Drug: sotagliflozinsubjects with severe hepatic impairment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male and female subjects ≥18 to ≤70 years of age
- Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening
- Subjects with mild, moderate, or severe hepatic impairment
- Control group of matched healthy subjects
- Willing and able to provide written informed consent
Key exclusion criteria (5 listed)
- Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
- Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
- History of any major surgery within 6 months
- History of renal disease, or significantly abnormal kidney function test
- Women who are breastfeeding or are planning to become pregnant during 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 |
|---|---|---|
| sotagliflozinsingle 400 mg dose | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
Time frame: Day 1 to Day 5
1 secondary outcome
Number of treatment emergent adverse events
Time frame: Day 1 to Day 8
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 17 Nov 2016.
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sotagliflozin in people with Hepatic Impairment and Healthy, run by Lexicon Pharmaceuticals at 4 sites 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 5 inclusion and 5 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters (time frame: Day 1 to Day 5). 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 17 Nov 2016.