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Phase 2 N=36 Randomized Quadruple-blind Treatment

Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants

Diabetic Gastroparesis · Idiopathic Gastroparesis

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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