Status:
COMPLETED
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)
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants with Gastroparesis (GP).
Detailed Description
The drug being tested in this study is called TAK-906 maleate. TAK-906 maleate is being tested to treat people who have DG or IG. This study will assess the safety, tolerability, PK/PD and food effect...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- In order to be eligible for participation in this trial, the participant must:
- 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
- The participant must be excluded from participating in the trial if the participant:
- 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.
- 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.
- Has active diverticulitis, diverticular stricture, and other intestinal strictures.
- 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.
- Has had diabetic ketoacidosis (within the prior 4 weeks).
Exclusion
Key Trial Info
Start Date :
September 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2018
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03268941
Start Date
September 26 2017
End Date
March 9 2018
Last Update
January 6 2021
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
9171 West Thunderbird Road
Peoria, Arizona, United States, 85381
2
850 North Kolb Road
Tucson, Arizona, United States, 85710
3
11219 Financial Centre Parkway
Little Rock, Arkansas, United States, 72211
4
13055 Southwest 42nd Street
Miami, Florida, United States, 33175