Type 2 Diabetes MellitusPhase 1NCT03417076
Absolute Bioavailability Study With Bexagliflozin
A Phase 1 study testing Bexagliflozin in people with Type 2 Diabetes Mellitus, run by Theracos at 1 site in United States.
Trial summary
The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy 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, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 16 Sep 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
- no nicotine and tobacco consumption in the past 3 months
- willing and able to be confined to the clinical research facility as required by the protocol
Who cannot join
- clinically significant history of allergy to drugs or latex
- history of alcohol or drug dependence in the past 12 months.
- donation of a significant amount of blood in the past 2 months
- willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic
- exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Center, Open-label, Single Period, Non-randomized Study to Determine the Absolute Bioavailability of Bexagliflozin Tablets Following a Single Oral Dose Co-administered With an Intravenous Microtracer Dose of 14C-Bexagliflozin in Healthy Male Subjects
The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.
- 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 tablets, 20 mg, and bexagliflozin by IV
| Study group | Role | What they receive |
|---|---|---|
| Bexagliflozin | Experimental | Each subject will receive a single oral dose of bexagliflozin tablets, 20 mg, followed by a single IV dosing of < 30 ug 14C-bexagliflozin in 0.9% saline solution). Receives: Drug: Bexagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute bioavailability (Fp.o.) of bexagliflozin tablets
oral to IV ratio of dose-normalized AUC0-inf (area under the plasma concentration time curve extrapolated to infinity)
Measured: Up to 48 hours
Secondary outcomes (1)
adverse events
adverse event as a measure of safety and tolerability of treatment
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Aug 2018 (estimated)
- Primary completion16 Sep 2018 (estimated)
- Study completion16 Sep 2018 (estimated)
Why it stopped: Sponsor decision to not initiate study due to sufficient bioavailability information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theracos
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mason Freeman, M.D., Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417076
- Sponsor's protocol ID
- THR-1442-C-446
- Status last verified
- Sep 2019
- First submitted
- 24 Jan 2018
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Open-label, Single Period, Non-randomized Study to Determine the Absolute Bioavailability of Bexagliflozin Tablets Following a Single Oral Dose Co-administered With an Intravenous Microtracer Dose of 14C-Bexagliflozin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03417076
- Acronym / sponsor ID
- THR-1442-C-446
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to not initiate study due to sufficient bioavailability information
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TheracosIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 16 Sep 2018 (estimated)
- Study completion
- 16 Sep 2018 (estimated)
- First posted
- 31 Jan 2018 (actual)
- 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 purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bexagliflozin | Experimental | Drug: BexagliflozinEach subject will receive a single oral dose of bexagliflozin tablets, 20 mg, followed by a single IV dosing of < 30 ug 14C-bexagliflozin in 0.9% saline solution). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
- no nicotine and tobacco consumption in the past 3 months
- willing and able to be confined to the clinical research facility as required by the protocol
Key exclusion criteria (5 listed)
- clinically significant history of allergy to drugs or latex
- history of alcohol or drug dependence in the past 12 months.
- donation of a significant amount of blood in the past 2 months
- willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic
- exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
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 tablets, 20 mg, and bexagliflozin by IV | Drug | Bexagliflozin |
Primary outcome
absolute bioavailability (Fp.o.) of bexagliflozin tablets
Time frame: Up to 48 hours
oral to IV ratio of dose-normalized AUC0-inf (area under the plasma concentration time curve extrapolated to infinity)
1 secondary outcome
adverse events
Time frame: Up to 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- 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.
Mason Freeman, M.D. study director
Massachusetts General Hospital
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?
The sponsor lists 3 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: withdrawn, as of the sponsor's last update on 30 Sep 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
absolute bioavailability (Fp.o.) of bexagliflozin tablets (time frame: Up to 48 hours). 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 Sep 2019.