Diabetes MellitusPhase 1NCT02120976
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
A Phase 1 study testing JTT-252 in people with Diabetes Mellitus, run by Shionogi Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2 diabetes mellitus subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- JTT-252
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subject Cohorts:
- Healthy male or female subjects
- Age 18 to 50 Years (inclusive)
- Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive)
- Type 2 Diabetic Subject Cohorts:
- Male or female Type 2 diabetic subjects who are currently being treated with a stable dose of metformin
Show all 10Show fewer
- Age 18 to 65 Years (inclusive)
- BMI between 25.0 and 40.0 kg/m2 (inclusive)
- Have a glycosylated hemoglobin (HbA1c) of >7.0% to ≤9.5%
- Have a fasting plasma glucose (FPG) <240 mg/dL
Who cannot join
- Healthy Subject Cohorts:
- Known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic and dermatological or connective tissue disease
- Subjects with a systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg
- Type 2 Diabetic Subject Cohorts:
- Subjects with a known medical history or presence of type 1 diabetes mellitus
- Subjects with known medical history of acute metabolic diabetic complications
- Subjects with uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Austin, Texas
Study site
Overland Park, Kansas
About this study
Official title: A Phase 1, Randomized, Single-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Single Oral Doses of JTT-252 in Healthy Subjects (Part I); in Conjunction With an Open-label Study to Evaluate the Effect of Food on the PK of JTT-252 in Healthy Subjects (Part II); and an Open-label Study to Evaluate the Safety, Tolerability, PK and Pharmacodynamics (PD) of Single Oral Doses of JTT-252 in Type 2 Diabetic Subjects (Part III)
The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2 diabetes mellitus subjects.
- Conditions
- Diabetes Mellitus
- Being tested
- JTT-252 or Placebo, JTT-252
- Keywords
- Safety, Tolerability, Pharmacokinetics, Food-effect, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTT-252 or PlaceboDrug
Subjects will receive JTT-252 or Placebo
JTT-252Drug
Subjects will receive JTT-252
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 or Placebo |
| Dose 2 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 or Placebo |
| Dose 3 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 or Placebo |
| Dose 4 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 or Placebo |
| Dose 5 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 or Placebo |
| Dose 6 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 or Placebo |
| Dose 7 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 or Placebo |
| Dose 8 JTT-252 | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-252 |
| Dose 9 JTT-252 | Experimental | Tablets, single dose in fasted condition Receives: Drug: JTT-252 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 22 days
Vital signs and 12 lead ECGs
Measured: 22 days
Cmax (maximum concentration)
Measured: 22 days
t1/2 (elimination half-life)
Measured: 22 days
AUC (area under the concentration-time curve)
Measured: 22 days
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
Measured: 3 days
Plasma glucose
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuichiro Neki, Study chair, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120976
- Sponsor's protocol ID
- AT252-U-14-001
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Single Oral Doses of JTT-252 in Healthy Subjects (Part I); in Conjunction With an Open-label Study to Evaluate the Effect of Food on the PK of JTT-252 in Healthy Subjects (Part II); and an Open-label Study to Evaluate the Safety, Tolerability, PK and Pharmacodynamics (PD) of Single Oral Doses of JTT-252 in Type 2 Diabetic Subjects (Part III)
- ClinicalTrials.gov ID
- NCT02120976
- Acronym / sponsor ID
- AT252-U-14-001
- Conditions
- Diabetes Mellitus
- Keywords
- Safety, Tolerability, Pharmacokinetics, Food-effect, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Apr 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.
The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2 diabetes mellitus subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Dose 1 JTT-252 or Placebo | Experimental | Drug: JTT-252 or PlaceboTablets, single dose in fasted condition |
| Dose 2 JTT-252 or Placebo | Experimental | Drug: JTT-252 or PlaceboTablets, single dose in fasted condition |
| Dose 3 JTT-252 or Placebo | Experimental | Drug: JTT-252 or PlaceboTablets, single dose in fasted condition |
| Dose 4 JTT-252 or Placebo | Experimental | Drug: JTT-252 or PlaceboTablets, single dose in fasted condition |
| Dose 5 JTT-252 or Placebo | Experimental | Drug: JTT-252 or PlaceboTablets, single dose in fasted condition |
| Dose 6 JTT-252 or Placebo | Experimental | Drug: JTT-252 or PlaceboTablets, single dose in fasted condition |
| Dose 7 JTT-252 or Placebo | Experimental | Drug: JTT-252 or PlaceboTablets, single dose in fasted condition |
| Dose 8 JTT-252 | Experimental | Drug: JTT-252Tablets, single dose in fed condition |
| Dose 9 JTT-252 | Experimental | Drug: JTT-252Tablets, single dose in fasted condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy male or female subjects
- Age 18 to 50 Years (inclusive)
- Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive)
- Male or female Type 2 diabetic subjects who are currently being treated with a stable dose of metformin
- Age 18 to 65 Years (inclusive)
Key exclusion criteria (7 listed)
- Known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic and dermatological or connective tissue disease
- Subjects with a systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg
- Subjects with a known medical history or presence of type 1 diabetes mellitus
- Subjects with known medical history of acute metabolic diabetic complications
- Subjects with uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg
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 |
|---|---|---|
| JTT-252 or PlaceboSubjects will receive JTT-252 or Placebo | Drug | Dose 1 JTT-252 or Placebo, Dose 2 JTT-252 or Placebo, Dose 3 JTT-252 or Placebo, Dose 4 JTT-252 or Placebo, Dose 5 JTT-252 or Placebo, Dose 6 JTT-252 or Placebo, Dose 7 JTT-252 or Placebo |
| JTT-252Subjects will receive JTT-252 | Drug | Dose 8 JTT-252, Dose 9 JTT-252 |
Primary outcome
Number of subjects with adverse events
Time frame: 22 days
Vital signs and 12 lead ECGs
Time frame: 22 days
Cmax (maximum concentration)
Time frame: 22 days
t1/2 (elimination half-life)
Time frame: 22 days
AUC (area under the concentration-time curve)
Time frame: 22 days
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
Time frame: 3 days
Plasma glucose
Time frame: 22 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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.
Yuichiro Neki study chair
Shionogi Inc.
2 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 JTT-252 in people with Diabetes Mellitus, run by Shionogi Inc. at 2 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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early. Results are not available in the source record.
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?
Number of subjects with adverse events (time frame: 22 days). The study lists 7 primary outcomes in all. 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 1 May 2015.