A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)
Condition: Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis
MeSH terms: Gastroparesis; Diabetes Mellitus
Intervention: TAK-906 Maleate; Metaclopramide; TAK-906 Maleate Placebo
Intervention description: TAK-906 Maleate Capsules; Metaclopramide Tablets; TAK-906 placebo-matching Capsules
Intervention MeSH terms: Metoclopramide; Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The study has two parts: Part 1 (double-blind) and Part 2 (open-label).
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants
      with Gastroparesis (GP).
    

Eligibility criteria:

        Inclusion Criteria

        In order to be eligible for participation in this trial, the participant must:

          1. Has a documented diagnosis of diabetes mellitus gastroparesis (DG) or idiopathic
             gastroparesis (IG).

          2. Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to
             (<=) 40 kilogram per square meter (kg/m^2) at the Screening Visit.

          3. Be a non-smoker who has not used tobacco or nicotine-containing products (example,
             nicotine patch) for at least 6 months prior to trial drug administration of the
             initial dose of trial drug/invasive procedure.

          4. Has symptoms for gastroparesis (GP) (that is, chronic postprandial fullness, abdominal
             pain, postprandial nausea, vomiting, loss of appetite and/or early satiety) the past 3
             months.

          5. Has documented slow gastric emptying (GE), with delayed GE by 13C-Spirulina gastric
             emptying breath test (GEBT) at Screening defined as >=80th percentile. Note: If a
             participant has had a documented scintigraphy or GEBT within the last 12 months that
             confirms the diagnosis of delayed GE, a screening GEBT would not be required.

          6. Has nausea subscale (of American Neurogastroenterology and Motility Society
             Gastroparesis Cardinal Symptom Index-Daily Diary [ANMS-GCSI-DD]) symptom score >=2 at
             least 3 of 7 days during Screening.

          7. Has haemoglobin A1c (HBA1c) less than (<) 10 percent (%) (for diabetes mellitus only).

        Exclusion Criteria

        The participant must be excluded from participating in the trial if the participant:

          1. Has acute severe gastroenteritis and pronounced dehydration in the past 48 hours prior
             to Screening, gastric pacemaker, chronic parenteral feeding or persistent severe
             vomiting.

          2. Has a known disturbance of small intestinal absorption, exocrine pancreatic function,
             liver metabolism, and pulmonary function.

          3. Has a history of anorexia nervosa or bulimia.

          4. Previous history of bezoars (the presence of retained liquid, bile, or small amounts
             of poorly organized food residue is permitted).

          5. Difficulty swallowing solid food or pills.

          6. Prior surgery involving the luminal gastrointestinal (GI) tract (cholecystectomy,
             appendectomy, and hysterectomy are permitted if performed greater than (>) 3 months
             prior to SmartPill test).

          7. Any abdominal or pelvic surgery within the past 3 months.

          8. Known or history of inflammatory bowel disease.

          9. Has active diverticulitis, diverticular stricture, and other intestinal strictures.

         10. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL])
             within 4 weeks prior to the pretrial (screening) visit milligram per deciliter (mg/dL)
             (14.99 millimole per liter [mmol/L]) during any visit up to and including the
             randomization visit (Period 1 Day 1 predose). Note: If the participant meets this
             exclusion criterion and the investigator believes that the value is not consistent
             with the participant's current self-monitoring blood glucose values, the participant
             should not be excluded at this time. The visit can be repeated within 5 to 7 days.

         11. Has had diabetic ketoacidosis (within the prior 4 weeks).