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)
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Diabetes |
Therapuetic Areas: | Endocrinology, Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/17/2018 |
Start Date: | September 26, 2017 |
End Date: | March 10, 2018 |
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).
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 GE.
The study will enroll a total of approximately 48 participants. This study will be conducted
in two parts: Part 1 and Part 2. Part 1 will consist of 48 participants enrolled in 4 active
treatment groups. Each treatment group will enroll 12 participants with a minimum of 4 DG and
IG participants in each group. Participants in Part 1 will be randomly assigned (by chance,
like flipping a coin) to one of the four active treatment groups—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 will consist of 18 participants who completed Part 1 and will be assigned to
the 2 treatment groups as follow:
- TAK-906 maleate 25 mg Fed + TAK-906 maleate 25 mg Fasted
- 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.
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 GE.
The study will enroll a total of approximately 48 participants. This study will be conducted
in two parts: Part 1 and Part 2. Part 1 will consist of 48 participants enrolled in 4 active
treatment groups. Each treatment group will enroll 12 participants with a minimum of 4 DG and
IG participants in each group. Participants in Part 1 will be randomly assigned (by chance,
like flipping a coin) to one of the four active treatment groups—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 will consist of 18 participants who completed Part 1 and will be assigned to
the 2 treatment groups as follow:
- TAK-906 maleate 25 mg Fed + TAK-906 maleate 25 mg Fasted
- 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.
Inclusion Criteria
In order to be eligible for participation in this trial, the participant must:
1. Has a documented diagnosis of DG or 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 nonsmoker 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 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 GE, with delayed GE by 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 hemoglobin 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 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).
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