NCT04520360 is a Phase 1 clinical trial of Carisbamate in Healthy Subjects, sponsored by SK Life Science, Inc..

Who is sponsoring NCT04520360?

NCT04520360 is sponsored by SK Life Science, Inc..

What drugs are being tested in NCT04520360?

Interventions in NCT04520360: Carisbamate.

What condition does NCT04520360 study?

NCT04520360 studies Healthy Subjects.

Is NCT04520360 still recruiting?

NCT04520360 is currently completed. Last updated 7 October 2021.

Last reviewed 2021-10-07 · How we verify

NCT04520360

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bioavailability and Food Effect Study of 3 Types of Carisbamate

Completed Phase 1 Last updated 7 October 2021

What this trial tests

Phase 1 trial testing Carisbamate in Healthy Subjects in 33 participants. Completed in 6 October 2021.

Timeline

27 August 2020

Primary endpoint
6 October 2021

6 October 2021

Quick facts

Lead sponsor	SK Life Science, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	27 August 2020
Primary completion	6 October 2021
Estimated completion	6 October 2021
Sites	1 location across United States

Drugs / interventions tested

Carisbamate — full drug profile →

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

SK Life Science, Inc. — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Carisbamate

Trials testing the same drug.

NCT04062981 — Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome · Phase 1 · completed
NCT03731715 — Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome · Phase 1 · completed

Other recruiting trials for Healthy Subjects

Currently open trials in the same condition.

NCT07222020 — Phase 1 Study of Intravaginal KB15A · Phase 1 · recruiting
NCT07350538 — The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL · NA · active not recruiting
NCT07304791 — This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and P · Phase 1 · recruiting
NCT07059858 — Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities · recruiting
NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · Phase 1 · recruiting

Other SK Life Science, Inc. trials

Trials by the same sponsor.

NCT06453213 — Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy · Phase 4 · active not recruiting
NCT05572255 — A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Admini · Phase 1 · completed
NCT05388435 — Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients · Phase 1, PHASE2 · terminated
NCT04791553 — Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment · Phase 1 · completed
NCT04903314 — Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04520360 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SK Life Science, Inc.
Last refreshed: 7 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04520360.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing