Phase 2
N=36
Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants
Diabetic Gastroparesis · Idiopathic Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT03281577 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Jul 2020
Primary outcome: Primary: Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids — 3.5; -19.8; -25.4; -25.7 percent change — p=0.0012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAK-954 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids |
3.5; -19.8; -25.4; -25.7 | 0.0012 sig |
| SECONDARY Colonic Geometric Center |
0.539; 1.190; 1.737; 1.148; 1.965; 3.792 | 0.2590 |
| SECONDARY Colonic Filling at Hour 6 |
31.3; 55.6; 86.4; 75.3 | 0.0436 sig |
| SECONDARY Half-emptying Time (T1/2) of Ascending Colon |
19.1; 5.4; 6.3; 7.4 | 0.0789 |
| SECONDARY AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954 |
8.99; 25.79; 83.75; 12.16; 33.94; 109.86 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-954 |
1.637; 5.346; 16.029; 1.687; 5.821; 15.517 | — |
| SECONDARY Ctrough: Observed Plasma Concentration at the End of a Dosing Interval |
0.1969; 0.4364; 1.6817; 0.2854; 0.6392; 2.2620 | — |
Summary
The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.
Eligibility Criteria
Inclusion Criteria
- Has diabetes mellitus with symptoms of gastroparesis and previously documented gastric emptying delay or previously documented idiopathic gastroparesis in the last 5 years.
- Has a body mass index (BMI) greater than or equal to (>=) 16 and less than or equal to ( ) 12 percent (%).
- Has other structural diseases/conditions that affect the gastrointestinal (GI) system.
- Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.
- Has clinically significant abnormal baseline safety laboratory values.
- Has preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
- Are without known preexisting hepatic disease who have 1 or more of the following:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal (ULN).
- Bilirubin >1.5 times the ULN unless due to Gilbert's syndrome.
- International normalized ratio (INR) >1.5 unless on anticoagulation therapy.
- Has QT intervals with Fridericia correction method (QTcF) interval (>=) 460 millisecond (msec) or with other factors that increase the risk of QT prolongation or arrhythmic events at screening. Note: Participants with bundle branch block and a prolonged QTc interval, or with QTcF between 450 and 460 msec, should be reviewed by the Medical Monitor for potential inclusion.
- Has second or third degree atrioventricular (AV) block; AV disassociation; >5 beats of non-sustained VT at a rate >120 beats per minute (bpm); Electrocardiogram (ECG) changes consistent with acute myocardial ischemia or infarction.
- Has cardiac history that includes conditions requiring heart rate control (example, atrial fibrillation, atrial flutter, ventricular tachycardia, or other tachyarrhythmias).
- Has clinical evidence (including physical examination, ECG, clinical laboratory value and review of the medical history) of significant cardiovascular, respiratory, moderate or severe renal insufficiency (creatinine clearance <=60 mL/min), hematological, neurological, or psychiatric disease, or other disease that interferes with the objectives of the study.
- If female, are pregnant or lactating or intending to become pregnant before participating in this study, during the study, and 4 to 5 days (5 half-lives) PLUS 30 days after last dose of the study drug; or intending to donate ova during such time period.
- Are considered by the investigator to be alcoholics not in remission or known substance abusers. Have a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 milliliter per [mL/] 12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
Data sourced from ClinicalTrials.gov (NCT03281577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.