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COMPLETED Phase 1

Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects

NCT02676596 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.

Conditions Studied

Interventions

  • DRUG K-312 10 mg QD
  • DRUG K-312 25 mg QD
  • DRUG K-312 50 mg QD
  • DRUG K-312 100 mg QD
  • DRUG K-312 200 mg QD

Study Locations (1)

California

  • — Glendale

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2014-04
Est. Completion 2015-01
Phase Phase 1

Sponsor

Kowa Research Institute

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02676596

The ClinicalTrials.gov registry entry for NCT02676596 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kowa Research Institute, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hyperlipidemia appearing as the primary indexed condition, and to 5 interventions — of which K-312 10 mg QD is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02676596 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02676596 about?

NCT02676596 is a clinical study titled "Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects". The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.

What is the current status of trial NCT02676596?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2014-04. Estimated completion is 2015-01.

What conditions does trial NCT02676596 study?

This clinical trial studies the following conditions: Hyperlipidemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02676596?

The interventions under investigation include: K-312 10 mg QD (DRUG), K-312 25 mg QD (DRUG), K-312 50 mg QD (DRUG), K-312 100 mg QD (DRUG), K-312 200 mg QD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02676596?

This trial is sponsored by Kowa Research Institute, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02676596 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial