A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Pa… (NCT03268941) | Clinical Trial Compass
CompletedPhase 2
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)
United States51 participantsStarted 2017-09-26
Plain-language summary
The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants with Gastroparesis (GP).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Has a documented diagnosis of diabetes mellitus gastroparesis (DG) or idiopathic gastroparesis (IG).
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. Has haemoglobin A1c (HBA1c) less than (\<) 10 percent (%) (for diabetes mellitus only).
Exclusion criteria
✕. Has acute severe gastroenteritis and pronounced dehydration in the past 48 hours prior to Screening, gastric pacemaker, chronic parenteral feeding or persistent severe vomiting.
✕. Has a known disturbance of small intestinal absorption, exocrine pancreatic function, liver metabolism, and pulmonary function.
What they're measuring
1
Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
2
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Timeframe: From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days)
3
Number of Participants With Markedly Abnormal Vital Signs
Timeframe: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
4
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
Timeframe: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
✕. Has a history of anorexia nervosa or bulimia.
✕. Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
✕. Difficulty swallowing solid food or pills.
✕. Prior surgery involving the luminal gastrointestinal (GI) tract (cholecystectomy, appendectomy, and hysterectomy are permitted if performed greater than (\>) 3 months prior to SmartPill test).
✕. Any abdominal or pelvic surgery within the past 3 months.
✕. Known or history of inflammatory bowel disease.