Diabetes MellitusPhase 1NCT02106585
Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
A Phase 1 study of Diabetes Mellitus, run by Shionogi Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subject Cohorts:
- Healthy male or female subjects
- 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 diagnosed for at least 3 months
- BMI between 25 and 40 kg/m2 (inclusive)
- Have a glycosylated hemoglobin (HbA1c) of >6.5% to ≤10.9% (inclusive) if treatment naïve with respect to hypoglycemic agents OR >6.5% to ≤10.0% (inclusive) if treated with metformin
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 >150 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 >160 mmHg and/or diastolic blood pressure >95 mmHg with documented ongoing treatment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomized, Single-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of JTT-251 Single Oral Doses in Healthy Subjects (Part Ia) and in Type 2 Diabetic Subjects (Part Ib) and Randomized, Open-label, Crossover Study Evaluating Effect of Food on PK in Healthy Subjects (Part II)
The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects.
- Conditions
- Diabetes Mellitus
- Being tested
- JTT-251 or Placebo
- 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-251 or PlaceboDrug
Subjects will receive JTT-251 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 2 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 3 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 4 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 5 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 6 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 7 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 8 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition Receives: Drug: JTT-251 or Placebo |
| Dose 9 JTT-251 or Placebo | Experimental | Tablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition Receives: Drug: JTT-251 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 1 week
Vital signs and 12 lead ECGs
Measured: 1 week
Cmax (maximum concentration)
Measured: 1 week
t1/2 (elimination half-life)
Measured: 1 week
AUC (area under the concentration-time curve)
Measured: 1 week
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideyuki Yamamoto, Study chair, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106585
- Sponsor's protocol ID
- AT251-U-13-001
- Status last verified
- Oct 2014
- First submitted
- 4 Apr 2014
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Single-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of JTT-251 Single Oral Doses in Healthy Subjects (Part Ia) and in Type 2 Diabetic Subjects (Part Ib) and Randomized, Open-label, Crossover Study Evaluating Effect of Food on PK in Healthy Subjects (Part II)
- ClinicalTrials.gov ID
- NCT02106585
- Acronym / sponsor ID
- AT251-U-13-001
- Conditions
- Diabetes Mellitus
- Keywords
- Safety, Tolerability, Pharmacokinetics, Food-effect, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 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 (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy 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-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 2 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 3 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 4 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 5 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 6 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 7 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 8 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fed condition |
| Dose 9 JTT-251 or Placebo | Experimental | Drug: JTT-251 or PlaceboTablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male or female subjects
- Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive)
- Male or female Type 2 diabetic subjects diagnosed for at least 3 months
- BMI between 25 and 40 kg/m2 (inclusive)
- Have a glycosylated hemoglobin (HbA1c) of >6.5% to ≤10.9% (inclusive) if treatment naïve with respect to hypoglycemic agents OR >6.5% to ≤10.0% (inclusive) if treated with metformin
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 >150 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 >160 mmHg and/or diastolic blood pressure >95 mmHg with documented ongoing treatment)
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-251 or PlaceboSubjects will receive JTT-251 or Placebo | Drug | Dose 1 JTT-251 or Placebo, Dose 2 JTT-251 or Placebo, Dose 3 JTT-251 or Placebo, Dose 4 JTT-251 or Placebo, Dose 5 JTT-251 or Placebo, Dose 6 JTT-251 or Placebo, Dose 7 JTT-251 or Placebo, Dose 8 JTT-251 or Placebo, Dose 9 JTT-251 or Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: 1 week
Vital signs and 12 lead ECGs
Time frame: 1 week
Cmax (maximum concentration)
Time frame: 1 week
t1/2 (elimination half-life)
Time frame: 1 week
AUC (area under the concentration-time curve)
Time frame: 1 week
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
Time frame: 1 week
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 7 Oct 2014.
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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.
Hideyuki Yamamoto study chair
Shionogi 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 of Diabetes Mellitus, run by Shionogi Inc. 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 7 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: finished, as of the sponsor's last update on 7 Oct 2014. 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?
Number of subjects with adverse events (time frame: 1 week). The study lists 6 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 7 Oct 2014.