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Also known as TAK-648 Tablet
TAK-648 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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). |
| Name | Type | Description |
|---|---|---|
| TAK-648 | DRUG | TAK-648 solution |
| Placebo | DRUG | TAK-648 placebo-matching solution |
Inclusion Criteria: Part 1: 1. Is an adult male or female and has a historical diagnosis of type 2 diabetes mellitus (T2DM) disease. 2. Is aged 18 to 65 years, inclusive, at the time of informed consent and first study medication dose. 3. Weighs at least 55 kg and has a body mass index (BMI) ≥23.0...
TAK-648 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for Type 2 Diabetes Mellitus. It is also referred to as TAK-648 Tablet. The drug has been studied in a Phase 1 clinical trial and is not approved for commercial use.
TAK-648 is being developed for the treatment of Type 2 Diabetes Mellitus, a metabolic condition. Its clinical evaluation has focused on this indication, and it remains an investigational agent rather than an approved therapy for patients.
TAK-648 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company sponsored the Phase 1 clinical program evaluating the compound in participants with Type 2 Diabetes Mellitus and in healthy volunteers.
TAK-648 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
TAK-648 has been evaluated in one completed Phase 1 trial, NCT02430870, titled a multiple-rising dose study in healthy Japanese participants and non-Japanese participants with Type 2 Diabetes Mellitus. The trial enrolled 48 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, TAK-648 Tablet is an alternative name for TAK-648. Both names refer to the same investigational small molecule developed by Takeda Pharmaceutical Company Limited for Type 2 Diabetes Mellitus, so searches using either name point to the same drug asset.