Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR

NCT04447820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-12-22

Study results available
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Summary

A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).

Conditions

Interventions

DRUG

K-877-ER (Dose A)

Dose A Oral Administration

DRUG

K-877-ER (Dose B)

Dose B Oral Administration

DRUG

K-877-IR

K-877-IR Oral Administration

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2020-12-03
Completion
2020-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04447820 on ClinicalTrials.gov