Bioavailability and Food Effect Study of 3 Types of Carisbamate

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
SK Life Science, Inc.
Study ID
NCT04520360
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Carisbamate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 27, 2020
Status verified
Jul 2020
Primary completion
Oct 6, 2021
Completion
Oct 6, 2021

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Types of Carisbamate
    1. A single 300 mg oral dose of the Oral Suspension Type 1 under fasting conditions 2. A single 300 mg oral dose of Oral Suspension Type 2 under fasting conditions 3. A single 300 mg oral dose of Oral Suspension Type 2 under fed conditions 4. A single oral dose of the 300 mg Oral Tablet under fasting conditions 5. A single oral dose of the 300 mg Oral Tablet under fed conditions

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 35 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRA Health Sciences- Salt Lake CitySalt Lake CityUtah84124-

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PRA Health Sciences- Salt Lake City· Salt Lake City, UT

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