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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)

NCT03268941 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-01-06

Study results available
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Summary

The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants with Gastroparesis (GP).

Conditions

  • Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis

Interventions

DRUG

TAK-906 Maleate

TAK-906 Maleate Capsules

DRUG

Metaclopramide

Metaclopramide Tablets

DRUG

TAK-906 Maleate Placebo

TAK-906 placebo-matching Capsules

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2018-03-09
Completion
2018-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03268941 on ClinicalTrials.gov