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The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-7284 | Experimental |
| |
| Placebo of TA-7284 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-7284 | Drug | Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events, Adverse Drug Reactions | In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose. | 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr | 19 days | |
| Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-One Clinic | Hachiōji | Tokyo-to | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26280756 | Derived | Iijima H, Kifuji T, Maruyama N, Inagaki N. Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Aug;32(8):768-82. doi: 10.1007/s12325-015-0234-0. Epub 2015 Aug 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TA-7284 25 mg | TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| FG001 | TA-7284 100 mg | TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| FG002 | TA-7284 200 mg | TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| FG003 | TA-7284 400 mg | TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| FG004 | Placebo | Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TA-7284 25 mg | TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| BG001 | TA-7284 100 mg | TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: Adverse Events, Adverse Drug Reactions | In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose. | Posted | Number | percentage of incidences | 19 days |
|
19 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TA-7284 25 mg | TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo of TA-7284 | Drug | Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days) |
|
| 18 days |
| BG002 | TA-7284 200 mg | TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| BG003 | TA-7284 400 mg | TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| BG004 | Placebo | Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| OG003 | TA-7284 400 mg | TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
| OG004 | Placebo | Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. |
|
|
| Secondary | Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr | Not Posted | 19 days | Participants |
| Secondary | Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin | Not Posted | 18 days | Participants |
| 0 |
| 12 |
| 9 |
| 12 |
| EG001 | TA-7284 100 mg | TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. | 0 | 12 | 8 | 12 |
| EG002 | TA-7284 200 mg | TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. | 0 | 14 | 5 | 14 |
| EG003 | TA-7284 400 mg | TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. | 0 | 13 | 6 | 13 |
| EG004 | Placebo | Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days. | 0 | 10 | 8 | 10 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 |
|
| Chills | General disorders | MedDRA 11.1 |
|
| Pyrexia | General disorders | MedDRA 11.1 |
|
| Herpes zoster | Infections and infestations | MedDRA 11.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 |
|
| Headache | Nervous system disorders | MedDRA 11.1 |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 11.1 |
|
| Albumin urine present | Investigations | MedDRA 11.1 |
|
| Beta 2 microglobulin urine increased | Investigations | MedDRA 11.1 |
|
| Blood uric acid increased | Investigations | MedDRA 11.1 |
|
| C-reactive protein increased | Investigations | MedDRA 11.1 |
|
| Blood urine present | Investigations | MedDRA 11.1 |
|
| N-telopeptide urine increased | Investigations | MedDRA 11.1 |
|
| Urine ketone body present | Investigations | MedDRA 11.1 |
|
| Fecal occult blood positive | Investigations | MedDRA 11.1 |
|
| Deoxypyridinoline urine increased | Investigations | MedDRA 11.1 |
|
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