Status:
COMPLETED
Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants
Lead Sponsor:
Takeda
Conditions:
Diabetic Gastroparesis
Idiopathic Gastroparesis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4) receptor agonist and is being tested to treat people who have diabetic or idiopathic gastroparesis and who previou...
Eligibility Criteria
Inclusion
- 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 (\<=) 40 kilogram per square meter (kg/m\^2) at the Screening Visit.
Exclusion
- Has glycosylated hemoglobin (HbA1c) greater than (\>) 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).
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03281577
Start Date
January 2 2018
End Date
July 12 2019
Last Update
January 7 2021
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905