Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-648 · 3 trials · 2 indications
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),
Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.
Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).
Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
| Arm | Type | Description |
|---|---|---|
| TAK-648 Sequence ABC | EXPERIMENTAL | Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3. |
| TAK-648 Sequence BCA | EXPERIMENTAL | Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3. |
| TAK-648 Sequence CAB | EXPERIMENTAL | Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3. |
| Part 1 Cohort 1: TAK-648 0.35 mg | EXPERIMENTAL | Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| Part 1 Cohort 2: TAK-648 0.80 mg | EXPERIMENTAL | Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| Part 1: Placebo Cohort 1-2 | PLACEBO_COMPARATOR | Participants with T2DM on a stable dose of metformin in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| Part 2 Cohort 1: TAK-648 0.05 mg | EXPERIMENTAL | Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2 Cohort 2: TAK-648 0.15 mg | EXPERIMENTAL | Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2 Cohort 3: TAK-648 0.35 mg | EXPERIMENTAL | Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2 Cohort 4: TAK-648 0.80 mg | EXPERIMENTAL | Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2: Placebo Cohort 1-4 | PLACEBO_COMPARATOR | Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Cohort 1: TAK-648 0.05 mg | EXPERIMENTAL | TAK-648 0.05 mg, solution, orally, once on Day 1. |
| Cohort 2: TAK-648 0.15 mg | EXPERIMENTAL | TAK-648 0.15 mg, solution, orally, once on Day 1. |
| Cohort 3: TAK-648 0.35 mg | EXPERIMENTAL | TAK-648 0.35 mg, solution, orally, once on Day 1. |
| Cohort 4: TAK-648 0.7 mg | EXPERIMENTAL | TAK-648 0.7 mg, solution, orally, once on Day 1. |
| Cohort 5: TAK-648 0.85 mg | EXPERIMENTAL | TAK-648 0.85 mg, solution, orally, once on Day 1. |
| Cohort 1-5: Placebo | PLACEBO_COMPARATOR | TAK-648 placebo-matching solution, orally, once on Day 1. |
| Name | Type | Description |
|---|---|---|
| TAK-648 Tablet | DRUG | Tak-648 tablet |
| TAK-648 Oral Solution | DRUG | TAK-648 oral solution |
| TAK-648 | DRUG | TAK-648 solution |
| Placebo | DRUG | TAK-648 placebo-matching solution |
| TAK-648 Placebo | DRUG | TAK-648 placebo-matching solution |
Inclusion Criteria: 1. Healthy male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose. 2. Weighs at least 50 kilogram (kg) (110 pounds \[lbs\]) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive at...
TAK-648 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus and in healthy volunteers. It is currently in Phase 1 clinical development, with studies completed in the United States.
TAK-648 is a small molecule being developed by Takeda Pharmaceutical Company Limited. Its specific molecular target has not been disclosed in the available clinical trial information.
TAK-648 is being developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker symbol TAK.
TAK-648 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three of its clinical trials have been completed.
TAK-648 has been studied in three completed Phase 1 trials: NCT02430870, a multiple-rising dose study in healthy Japanese and non-Japanese participants with Type 2 Diabetes Mellitus; NCT02480439, a relative bioavailability and food effect study in healthy participants; and NCT02684396, a single-rising dose study in healthy volunteers.
TAK-648 is the only name provided for this investigational drug. No alternative names have been reported in the clinical trial information.