Type 2 Diabetes MellitusPhase 1NCT02820298

Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects

A Phase 1 study testing Bexagliflozin in people with Type 2 Diabetes Mellitus, run by Theracos at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to investigate the effect of a high-fat meal on the levels of bexagliflozin in the blood in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Bexagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 20 Jun 2016to 29 Aug 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Each subject had to meet the following criteria to be eligible for the study:

Subjects who were between 18-65 years of age with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2.
Male subjects who were surgically sterile or male subjects who were not surgically sterile must have agreed to refrain from donating sperm and used appropriate birth control for a period of 30 days after discharge from the clinic.
Female subjects of childbearing potential who were willing to use an adequate method of contraception and to not become pregnant for the duration of the study.
Female subjects who were surgically sterile or postmenopausal were eligible if they tested negative on the urine pregnancy test.
Subjects who were non-smokers for at least 3 months prior to screening.
Subjects with adequate venous access at multiple sites in both arms.
Subjects who were willing and able to be confined to the clinical research facility as required by the Protocol.
Subjects who had the ability to comprehend and willingness to provide written informed consent in accordance with institutional and regulatory guidelines.

Subjects who met any of the following criteria were excluded from the study:

Subjects who were determined by the Investigator or sub-Investigator to be unsuitable for participating in the study based on medical conditions.
Female subjects who were nursing or pregnant.
Subjects with a clinically significant history of allergy to drugs or latex.
Subjects with a history of alcohol or drug dependence in the last 12 months.
Subjects who had 400 mL of whole blood collected within four months or 200 mL of whole blood collected within one month of the screening test.
Subjects who had blood component collection within 14 days prior to the screening test.
Subjects who had used prescription or over-the-counter drugs within 14 days prior to the first dose.
Subjects who had used vitamin preparations or supplements (including St. John's Wort and ginseng) within 14 days prior to the first dose.
Subjects who had undergone strenuous activity within 72 hours prior to Day 1 in each period.
Subjects who were unable (e.g., food intolerance) or unwilling to consume a high-fat breakfast within 25 minutes.
Subjects who had been treated with an investigational drug within 30 days or 7 half-lives of the investigational drug, whichever was longer, prior to the first dose of study drug in this trial.
Subjects who had previously received EGT0001474 or bexagliflozin, or any other SGLT2 inhibitors within 3 months from screening.
Subjects whose screening electrocardiogram (ECG) demonstrated any one of the following: heart rate >100 bpm, QRS >120 msec, QTc >470 msec (corrected by Bazett's formula), PR >220 msec (a subject with PR >220 msec would generally be excluded but exceptions may have been allowed at the discretion of the Investigator), or any rhythm that was not sinus rhythm, sinus bradycardia, or sinus arrhythmia.
Subjects whose sitting blood pressure was above 140/90 mmHg at screening.
Subjects who had a positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, urinary drug or urinary cotinine test.
Subjects with known human immunodeficiency virus (HIV) disease.
Subjects with abnormal vital signs, laboratory values, symptoms or signs that were deemed clinically significant by the Investigator.
Subjects who had had a febrile illness within 5 days prior to the first dose of study medication.
Subjects vaccinated within 30 days prior to the first dose of medication.
Detectable urine glucose at screening (trace or greater).
Subjects with eGFR <90 mL/min/1.73 m2 or a history of kidney transplant.
Subjects with digestion problems, including gastroesophageal reflux disease, irritable bowel syndrome, gastroparesis, and any other disorder deemed by the Investigator to be clinically significant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Denver Clinical Research Unit
Lakewood, Colorado, 80228

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Two-period, Two-treatment, Crossover Study to Evaluate the Effect of A High-Fat Meal on the Pharmacokinetics of Bexagliflozin in Healthy Subjects

The purpose of this study was to investigate the effect of a high-fat meal on the levels of bexagliflozin in the blood in healthy subjects.

Read the detailed description

This was a single center, Phase 1, open-label, 2 × 2 crossover study designed to assess the effects of a high-fat meal on the PK of orally administered bexagliflozin tablets in 18 healthy adults. Subjects were randomized 1:1 to receive bexagliflozin tablets with a high-fat meal on day 1 and without a meal on day 8 after an overnight fast or to receive bexagliflozin tablets without a meal on day 1 after an overnight fast and with a high-fat meal on day 8.

Subjects were admitted to the clinic on the day before dosing in each treatment period, and stayed in the clinic until 48 h post-dose.

The subjects dosed in the fed state received an oral bexagliflozin tablet, 20 mg, 30 min after starting to consume a high-fat meal following an overnight fast. The meal was to be ingested in its entirety over an approximate 25-minute period, such that it was completed at least 5 minutes prior to the scheduled time of bexagliflozin dosing for the fed state treatment. Subjects dosed in the fasting state received an oral bexagliflozin tablet, 20 mg, after an overnight fast.

Blood samples for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose. Urine collection in 12 h batches was performed at pre-dose (-12 to 0 h on day 0 and day 7), and at post-dose (0 to 12 h, 12 to 24 h, 24 to 36 h, and 36 to 48 h) intervals.

Conditions: Type 2 Diabetes Mellitus
Being tested: Bexagliflozin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BexagliflozinDrug
Also called EGT0001442, EGT0001474
Bexagliflozin tablet, 20 mg

Study groups in NCT02820298
Study group	Role	What they receive
Group 1 - Bexagliflozin dosed in fed state, then in fasted state	Experimental	Group 1 subjects will take one dose of 20 mg of bexagliflozin with food on day 1 after an overnight fast and will take a second dose of bexagliflozin without food on day 8 after an overnight fast. Receives: Drug: Bexagliflozin
Group 2 - Bexagliflozin in fasted state, then in fed state	Experimental	Group 2 subjects will take one dose of 20 mg bexagliflozin without food on day 1 after an overnight fast and will take a second dose of bexagliflozin with food on day 8 after an overnight fast. Receives: Drug: Bexagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (Maximum Observed Plasma Concentration)
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Tmax (Time of Maximum Observed Plasma Concentration)
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
AUC0-t (Area Under the Plasma Concentration-time Curve From Time 0 to t)
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time 0 to ∞)
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
T1/2 (Apparent Terminal Elimination Half-life)
Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201629 Aug 2016

First posted30 Jun 2016 (estimated)
Study start20 Jun 2016
Primary completion29 Aug 2016
Study completion29 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies 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: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02820298
Sponsor's protocol ID: THR-1442-C-481
Status last verified: May 2021
First submitted: 24 Jun 2016
Last updated: 10 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, Two-period, Two-treatment, Crossover Study to Evaluate the Effect of A High-Fat Meal on the Pharmacokinetics of Bexagliflozin in Healthy Subjects
ClinicalTrials.gov ID: NCT02820298
Acronym / sponsor ID: THR-1442-C-481
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: TheracosIndustry (pharma, biotech, devices)
Study start: 20 Jun 2016 (actual)
Primary completion: 29 Aug 2016 (actual)
Study completion: 29 Aug 2016 (actual)
First posted: 30 Jun 2016 (estimated)
Results: Posted 28 Apr 2021

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 was to investigate the effect of a high-fat meal on the levels of bexagliflozin in the blood in healthy subjects.

Detailed description

Subjects were admitted to the clinic on the day before dosing in each treatment period, and stayed in the clinic until 48 h post-dose.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 - Bexagliflozin dosed in fed state, then in fasted state	Experimental	Drug: BexagliflozinGroup 1 subjects will take one dose of 20 mg of bexagliflozin with food on day 1 after an overnight fast and will take a second dose of bexagliflozin without food on day 8 after an overnight fast.
Group 2 - Bexagliflozin in fasted state, then in fed state	Experimental	Drug: BexagliflozinGroup 2 subjects will take one dose of 20 mg bexagliflozin without food on day 1 after an overnight fast and will take a second dose of bexagliflozin with food on day 8 after an overnight fast.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
BexagliflozinAlso: EGT0001442, EGT0001474Bexagliflozin tablet, 20 mg	Drug	Group 1 - Bexagliflozin dosed in fed state, then in fasted state, Group 2 - Bexagliflozin in fasted state, then in fed state

Primary outcome

Cmax (Maximum Observed Plasma Concentration)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Tmax (Time of Maximum Observed Plasma Concentration)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
AUC0-t (Area Under the Plasma Concentration-time Curve From Time 0 to t)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time 0 to ∞)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
T1/2 (Apparent Terminal Elimination Half-life)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).

Results and safety

Results posted to the registry on 28 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bexagliflozin Administered in Fed Condition, Then in Fasted Condition	13	12
Bexagliflozin Administered in Fasted Condition, Then in Fed Condition	12	10

Primary outcome: Cmax (Maximum Observed Plasma Concentration)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose. Geometric least squares mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Bexagliflozin Tablet Dosed in Fed Condition n = 23	Bexagliflozin Tablet Dosed in Fasted Condition n = 24
Value	176.1 (30.6)	133.7 (42.5)

Bexagliflozin Tablet Dosed in Fed Condition vs Bexagliflozin Tablet Dosed in Fasted Condition: Ratio of Geometric LSM: 131.41 (90% CI 117.03 to 147.56)

Population analysed: The PK Population included all randomized subjects who received study drug and who had sufficient plasma bexagliflozin measurements to derive at least one PK parameter following dosing.

Primary outcome: Tmax (Time of Maximum Observed Plasma Concentration)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose. Median (Full Range). Unit: hours

Measure	Bexagliflozin Tablet Dosed in Fed Condition n = 23	Bexagliflozin Tablet Dosed in Fasted Condition n = 24
Value	5.0 (3 to 8)	3.5 (2 to 5)

Population analysed: PK population

Primary outcome: AUC0-t (Area Under the Plasma Concentration-time Curve From Time 0 to t)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose. Geometric least squares mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Bexagliflozin Tablet Dosed in Fed Condition n = 23	Bexagliflozin Dosed in Fasted Condition n = 24
Value	1222.7 (26.8)	1074.2 (33.0)

Bexagliflozin Tablet Dosed in Fed Condition vs Bexagliflozin Dosed in Fasted Condition: Ratio of Geometric LSM: 110.29 (90% CI 103.91 to 117.06)

Population analysed: PK population

Primary outcome: AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time 0 to ∞)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose. Geometric least squares mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Bexagliflozin Tablet Dosed in Fed Condition n = 23	Bexagliflozin Dosed in Fasted Condition n = 24
Value	1258.7 (5.8)	1161.8 (5.7)

Bexagliflozin Tablet Dosed in Fed Condition vs Bexagliflozin Dosed in Fasted Condition: Ratio of Geometric LSM: 108.34 (90% CI 102.48 to 114.54)

Population analysed: PK population

Adverse events

Time frame: The adverse event data were collected from Day 0 up to Day 10. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bexagliflozin Tablet Dosed in Fed Condition	0 of 23 (0%)	5 of 23 (21.7%)	0 of 23
Bexagliflozin Tablet Dosed in Fasted Condition	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Robert Williams, M.D. study director

Davita Clinical Research

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 Bexagliflozin in people with Type 2 Diabetes Mellitus, run by Theracos 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?

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 10 Jun 2021. 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?

Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax (Maximum Observed Plasma Concentration) (time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose). The study lists 5 primary outcomes in all. 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 NCT02820298.

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 10 Jun 2021.