MedTrace Logo

Treatment Development of Triheptanoin (G1D)

NCT03041363 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-12-22

No results posted yet for this study

Summary

To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed with glucose transporter type 1 deficiency disorder (G1D).

Conditions

  • Epilepsy
  • GLUT1DS1
  • Glut1 Deficiency Syndrome 1, Autosomal Recessive
  • Glucose Metabolism Disorders
  • Glucose Transport Defect
  • Glucose Transporter Type 1 Deficiency Syndrome
  • Glucose Transporter Protein Type 1 Deficiency Syndrome

Interventions

DRUG

Triheptanoin

Triheptanoin will be administered for 7 days 4 times daily.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Juan Pascual

    lead OTHER

Principal Investigators

  • Juan Pascual · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2017-12-22
Completion
2017-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03041363 on ClinicalTrials.gov