Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants

NCT03281577 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: TAK-954-2003U1111-1200-9396
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.

Conditions

Diabetic Gastroparesis; Idiopathic Gastroparesis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids

  Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.

  Predose and at multiple time-points post-dose (up to 9 hours) on Day 2

Secondary Outcomes (6)

• Colonic Geometric Center

  4, 24, and 48 hours post-radiolabeled meal on Day 2

• Colonic Filling at Hour 6

  6 hours post-radiolabel meal on Day 2

• Half-emptying Time (T1/2) of Ascending Colon

  Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3

• AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954

  Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3

• Cmax: Maximum Observed Plasma Concentration for TAK-954

  Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3

Study Arms (4)

Placebo

PLACEBO COMPARATOR

TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.

Drug: Placebo

TAK-954 0.1 mg

EXPERIMENTAL

TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.

Drug: TAK-954

TAK-954 0.3 mg

EXPERIMENTAL

TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days.

Drug: TAK-954

TAK-954 1 mg

EXPERIMENTAL

TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.

Drug: TAK-954

Interventions

TAK-954 DRUG

TAK-954 IV infusion.

TAK-954 0.1 mg; TAK-954 0.3 mg; TAK-954 1 mg

Placebo DRUG

TAK-954 placebo-matching IV infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has diabetes mellitus with symptoms of gastroparesis and previously documented gastric emptying delay or previously documented idiopathic gastroparesis in the last 5 years.
• Has a body mass index (BMI) greater than or equal to (\>=) 16 and less than or equal to (\<=) 40 kilogram per square meter (kg/m\^2) at the Screening Visit.

You may not qualify if:

• Has glycosylated hemoglobin (HbA1c) greater than (\>) 12 percent (%).
• Has other structural diseases/conditions that affect the gastrointestinal (GI) system.
• Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.
• Has clinically significant abnormal baseline safety laboratory values.
• Has preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
• Are without known preexisting hepatic disease who have 1 or more of the following:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 times the upper limit of normal (ULN).
• Bilirubin \>1.5 times the ULN unless due to Gilbert's syndrome.
• International normalized ratio (INR) \>1.5 unless on anticoagulation therapy.
• Has second or third degree atrioventricular (AV) block; AV disassociation; \>5 beats of non-sustained VT at a rate \>120 beats per minute (bpm); Electrocardiogram (ECG) changes consistent with acute myocardial ischemia or infarction.
• Has cardiac history that includes conditions requiring heart rate control (example, atrial fibrillation, atrial flutter, ventricular tachycardia, or other tachyarrhythmias).
• Has clinical evidence (including physical examination, ECG, clinical laboratory value and review of the medical history) of significant cardiovascular, respiratory, moderate or severe renal insufficiency (creatinine clearance \<=60 mL/min), hematological, neurological, or psychiatric disease, or other disease that interferes with the objectives of the study.
• If female, are pregnant or lactating or intending to become pregnant before participating in this study, during the study, and 4 to 5 days (5 half-lives) PLUS 30 days after last dose of the study drug; or intending to donate ova during such time period.
• Are considered by the investigator to be alcoholics not in remission or known substance abusers. Have a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer \[354 milliliter per \[mL/\] 12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\] per day).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Chedid V, Brandler J, Arndt K, Vijayvargiya P, Wang XJ, Burton D, Harmsen WS, Siegelman J, Chen C, Chen Y, Almansa C, Dukes G, Camilleri M. Randomised study: effects of the 5-HT4 receptor agonist felcisetrag vs placebo on gut transit in patients with gastroparesis. Aliment Pharmacol Ther. 2021 May;53(9):1010-1020. doi: 10.1111/apt.16304. Epub 2021 Mar 12.

  PMID: 33711180 DERIVED

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

takedadisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: January 2, 2018
• Primary Completion: June 7, 2019
• Study Completion: July 12, 2019
• Last Updated: January 7, 2021
• Results First Posted: July 15, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)