Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-954 · 7 trials · 7 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.
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
| 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. |
| [14C]-TAK-954 0.5 mg | EXPERIMENTAL | \[14C\]-TAK-954 0.5 milligram (mg), (containing approximately 1.5 microcurie \[µCi\] of radioactive tracer), administered as 60-minute infusion, intravenously, once on Day 1. |
| Sequence 1 | EXPERIMENTAL | Period 1: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 2: TAK-954 0.1 milligram (mg), infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period. |
| Sequence 2 | EXPERIMENTAL | Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg, infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period. |
| Sequence 3 | EXPERIMENTAL | Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg, infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg, infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. A washout period of at least 16 days will be maintained between each Treatment Period. |
| Group A TAK-954 0.2 mg: Healthy Participants | EXPERIMENTAL | Participants with normal renal function receive TAK-954 0.2 milligram (mg), infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
| Group B TAK-954 0.2 mg: Mild Renal Impairment | EXPERIMENTAL | Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
| Group C TAK-954 0.2 mg: Moderate Renal Impairment | EXPERIMENTAL | Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
| Group D TAK-954 0.2 mg: Severe Renal Impairment | EXPERIMENTAL | Participants without hemodialysis or End-stage Renal Disease (ESRD) receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
| Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) | EXPERIMENTAL | Participants with hemodialysis receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period. |
| Group 1 Mild Hepatic Impairment: TAK-954 0.2 mg | EXPERIMENTAL | TAK-954 0.2 milligram (mg), intravenous, administered as 60-minute infusion, once on Day 1. |
| Group 2 Moderate Hepatic Impairment: TAK-954 0.2 mg | EXPERIMENTAL | TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1. |
| Group 3 Severe Hepatic Impairment: TAK-954 0.2 mg | EXPERIMENTAL | TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1. |
| Group 4 Healthy Participants: TAK-954 0.2 mg | EXPERIMENTAL | TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1. |
| TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg | EXPERIMENTAL | TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period. |
| 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. |
| [14C]-TAK-954 | DRUG | \[14C\]-TAK-954 intravenous infusion. |
| Itraconazole | DRUG | Itraconazole Capsule |
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 studied for gastrointestinal conditions, including diabetic gastroparesis, idiopathic gastroparesis, and postoperative gastrointestinal dysfunction. It has also been evaluated in healthy volunteers and in people with renal or hepatic impairment to assess how the body processes the drug.
TAK-954 is being developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. Takeda is conducting clinical trials of TAK-954 across multiple countries, including the United States, Czechia, Hungary, and the Netherlands.
TAK-954 is in Phase 2 clinical development. A Phase 2 trial in diabetic or idiopathic gastroparesis has been completed, along with several Phase 1 studies in healthy volunteers and in people with renal impairment. The drug is investigational and has not been approved by regulatory authorities.
TAK-954 has completed four clinical trials. NCT03281577 was a Phase 2 study in diabetic or idiopathic gastroparesis. NCT03296787 evaluated renal impairment and dialysis effects. NCT03500224 studied mass balance and metabolism in healthy males, and NCT03870555 investigated safety and tolerability in healthy adults.
TAK-954 is the primary name used in clinical trial records for this investigational compound. No alternative names have been associated with TAK-954 in the available trial information, so it is not known to be the same as any other marketed or investigational drug.