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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Has diabetes mellitus with symptoms of gastroparesis and previously documented gastric emptying delay or previously documented idiopathic gastroparesis in the last 5 years.
  2. Has a body mass index (BMI) greater than or equal to (≥) 16 and less than or equal to (≤) 40 kilogram per meter square (kg/m^2) at the Screening Visit.

Exclusion Criteria:

  1. Have glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%).
  2. Have other structural diseases/conditions that affect the gastrointestinal (GI) system.
  3. Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.
  4. Have clinically significant abnormal baseline safety laboratory values.
  5. Have clinical evidence of significant cardiovascular, respiratory, moderate or severe renal insufficiency, hematological, neurological, or psychiatric disease, or other disease that interferes with the objectives of the study.
  6. Have 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).
  7. Are without known preexisting hepatic disease who have 1 or more of the following:
    • AST or 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.
  8. Have QT intervals with Fridericia correction method (QTcF) (QT corrected based on Fridericia's equation) 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 should be reviewed by the Medical Monitor for potential inclusion.
  9. Have cardiac history that includes conditions requiring heart rate control (example, atrial fibrillation, atrial flutter).
  10. Have second or third degree 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.
  11. 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.
  12. 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20368027

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