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A 2-Part, Randomized, Double Blind and Open-Label, Placebo and Active-Comparator Controlled Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics for TAK-906 in Subjects With Diabetes Mellitus and Gastroparesis or With Idiopathic Gastroparesis
The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants with Gastroparesis (GP).
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 of TAK-906 and will determine the effect of TAK-906 on gastric emptying (GE). The study enrolled a total of 51 participants. This study will be conducted in two parts: Part 1 and Part 2. Part 1 will consist of 48 participants enrolled in 3 active treatment groups and 1 placebo group. Participants in Part 1 will be randomly assigned (by chance, like flipping a coin) to one of the 3 active treatment groups or 1 placebo group-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * TAK 906 maleate 5 mg * TAK 906 maleate 25 mg * TAK 906 maleate 100 mg * Placebo All participants who will complete Part 1 of the study will be eligible for enrollment in Part 2. Part 2 consisted of 21 participants who completed Part 1 and were assigned to the 2 open-label treatment groups as follow: * TAK-906 maleate 25 mg Fed + TAK-906 maleate 25 mg Fasted: crossover design, with a minimum 7-day washout in doses of each period. * Metoclopramide 10 mg This multi-center trial will be conducted the United States. The overall time to participate in this study is approximately 8 weeks. Participants will make a final visit to the clinic 10-14 days after receiving their last dose of study drug for a follow-up assessment.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
9171 West Thunderbird Road
Peoria, Arizona, United States
850 North Kolb Road
Tucson, Arizona, United States
11219 Financial Centre Parkway
Little Rock, Arkansas, United States
13055 Southwest 42nd Street
Miami, Florida, United States
8200 Southwest 117th Avenue
Miami, Florida, United States
125 Clairemont Avenue
Decatur, Georgia, United States
616 South Washington Street
Bastrop, Louisiana, United States
6035 Shallowford Road
Chattanooga, Tennessee, United States
26 Stonecreek Circle
Jackson, Tennessee, United States
Start Date
September 26, 2017
Primary Completion Date
March 9, 2018
Completion Date
March 9, 2018
Last Updated
January 6, 2021
51
ACTUAL participants
TAK-906 Maleate
DRUG
Metaclopramide
DRUG
TAK-906 Maleate Placebo
DRUG
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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