Phase 2
N=51
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)
Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT03268941 ↗Enrolled (actual)
51
Serious AEs
2.6%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 4; 4; 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAK-906 Maleate (Drug); Metaclopramide (Drug); TAK-906 Maleate Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
4; 4; 3; 4; 1; 0 | — |
| PRIMARY Number of Participants With Markedly Abnormal Laboratory Parameters Values |
0; 1; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Markedly Abnormal Vital Signs |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values |
1; 1; 0; 0; 1; 1 | — |
| SECONDARY Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1 |
1.54; 12.77; 19.92; 20.07 | <0.001 sig |
| SECONDARY Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1 |
118.74; 130.18; 121.26; 122.50; 4.55; 6.21 | 0.599 |
| SECONDARY Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1 |
118.74; 130.18; 121.26; 122.50; -5.71; 0.12 | 0.522 |
| SECONDARY Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1 |
124.62; 61.72; 419.27; 71.09 | 0.274 |
| SECONDARY AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1 |
4.67; 23.0; 131; 5.46; 26.3; 166 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1 |
2.27; 12.0; 75.7; 2.87; 15.5; 99.6 | — |
| SECONDARY Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1 |
0.0121; 0.262; 0.770; 0.0423; 0.503; 0.958 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1 |
1.00; 1.00; 1.00; 1.00; 1.00; 0.98 | — |
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:
- 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 ( =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 ( ) 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).
Data sourced from ClinicalTrials.gov (NCT03268941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.