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Bioavailability and Food Effect Study of 3 Types of Carisbamate

NCT04520360 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-10-07

No results posted yet for this study

Summary

This study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet.

Conditions

  • Healthy Subjects

Interventions

DRUG

Carisbamate

Carisbamate is currently under investigation as an adjuvant antiepileptic therapy in Lennox-Gastaut patients. Lennox-Gastaut syndrome (LGS) is a rare and highly debilitating form of childhood epilepsy that typically is diagnosed between 2 and 8 years of age, with peak onset at 3 to 5 years of age, and frequently persists into adulthood. Treatment options are limited and complicated by the multiple seizure types associated with LGS. Given the breadth of physical and cognitive disabilities associated with LGS, the development of antiseizure medications with appropriate oral dosing forms is needed to ensure administration feasibility and compliance in the target population.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Ry R Forseth, Ph.D. · SK Life Science, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2021-10-06
Completion
2021-10-06
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 NCT04520360 on ClinicalTrials.gov