NCT02205099 is a Phase 1/Phase 2 clinical trial of SKL15508 in Schizophrenia, sponsored by SK Life Science, Inc..

Who is sponsoring NCT02205099?

NCT02205099 is sponsored by SK Life Science, Inc..

What drugs are being tested in NCT02205099?

Interventions in NCT02205099: SKL15508, Placebo.

What condition does NCT02205099 study?

NCT02205099 studies Schizophrenia.

Is NCT02205099 still recruiting?

NCT02205099 is currently completed. Last updated 12 October 2016.

Last reviewed 2016-10-12 · How we verify

NCT02205099

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

A Single-center, Randomized, Double-blind, Flexible-dosage, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia

Completed Phase 1/Phase 2 Last updated 12 October 2016

What this trial tests

Phase 1/Phase 2 trial testing SKL15508 in Schizophrenia in 39 participants. Completed in 1 June 2015.

Timeline

1 July 2014

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	SK Life Science, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	39
Start date	1 July 2014
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	1 location across United States

Drugs / interventions tested

SKL15508 — full drug profile →
Placebo

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

SK Life Science, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number and percent of subjects experiencing an adverse event.
Time frame: 10 days
Change from baseline in event-related potentials (ERP) following multiple oral doses of SKL15508.
Time frame: During the course of 10 days
Change from baseline in clinical laboratory assessments.
Time frame: 10 days
Change from baseline in vital signs.
Time frame: 10 days

Sponsor's own description

This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable schizophrenia.

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 recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · 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 NCT02205099 (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: 12 October 2016

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/NCT02205099.

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