CompletedPhase 2

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

United States36 participantsStarted 2018-01-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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 (\<=) 40 kilogram per square meter (kg/m\^2) at the Screening Visit.

Exclusion criteria

✕. 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:
✕. 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.

What they're measuring

Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids

Timeframe: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2

Trial details

NCT IDNCT03281577

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-07

Results submitted2020-05-28

View on ClinicalTrials.gov More Diabetic Gastroparesis trials