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Also known as [14C]-TAK-954
TAK-954 · 2 trials · 3 indications
The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.
Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.1 mg/100 mL | EXPERIMENTAL | TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.5 mg/100 mL | EXPERIMENTAL | TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.1 mg/100 mL + Placebo | EXPERIMENTAL | TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. |
| TAK-954 0.5 mg/100 mL + Placebo | EXPERIMENTAL | TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. |
| TAK-954 0.1 mg | EXPERIMENTAL | TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| TAK-954 0.3 mg | EXPERIMENTAL | TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days. |
| TAK-954 1 mg | EXPERIMENTAL | TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| Name | Type | Description |
|---|---|---|
| TAK-954 Placebo | DRUG | TAK-954 placebo-matching intravenous infusion. |
| TAK-954 | DRUG | TAK-954 intravenous infusion. |
| Placebo | DRUG | TAK-954 placebo-matching IV infusion. |
Inclusion Criteria: 1. Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection. 2. Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3. Exclusion Criteria: 1. Has significant mechanical bowel ob...
TAK-954 is an investigational small molecule being developed for gastrointestinal motility disorders. Its clinical development has focused on diabetic gastroparesis and postoperative gastrointestinal dysfunction, conditions in which impaired stomach or bowel movement causes symptoms after meals or after surgery. It is not approved and remains in Phase 2 testing.
TAK-954 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 2 clinical program evaluating the compound in patients with diabetic gastroparesis and postoperative gastrointestinal dysfunction.
TAK-954 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in postoperative gastrointestinal dysfunction and one in diabetic or idiopathic gastroparesis. No Phase 3 program has been reported, and the drug is investigational rather than approved.
TAK-954 has been studied in two completed Phase 2 trials. NCT03827655 evaluated TAK-954 in adults after surgery for postoperative gastrointestinal dysfunction, enrolling 209 participants in the United States and Germany. NCT03281577 assessed its effect on gastrointestinal and colonic transit in 36 participants with diabetic or idiopathic gastroparesis in the United States.
Yes. [14C]-TAK-954 is an alternative name for TAK-954. The carbon-14 label denotes a radiolabeled form of the same compound used in clinical study work, so searches for either name refer to the same Takeda development asset.
The TAK-954 Phase 2 trials were randomized, double-blind, and placebo-controlled. The postoperative gastrointestinal dysfunction study, NCT03827655, enrolled 209 adults aged 18 and older of any sex, while NCT03281577 enrolled 36 adults with diabetic or idiopathic gastroparesis. Both trials have been completed.