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Sequence A for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Kowa Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Awards & highlights

Study Summary

This trial seeks to compare the effects of a single drug to a combination of two drugs on healthy adult volunteers. It will also look at how food affects the drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour before dosing and at multiple time points (up to 48 hours) post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour before dosing and at multiple time points (up to 48 hours) post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-inf of K-877-and CSG452
AUC0-t of K-877 and CSG452
Cmax of K-877 and CSG452

Trial Design

6Treatment groups
Experimental Treatment
Group I: Sequence FExperimental Treatment3 Interventions
Three period alternative intervention and fed/fasted sequence
Group II: Sequence EExperimental Treatment3 Interventions
Three period alternative intervention and fed/fasted sequence
Group III: Sequence DExperimental Treatment3 Interventions
Three period alternative intervention and fed/fasted sequence
Group IV: Sequence CExperimental Treatment3 Interventions
Three period alternative intervention and fed/fasted sequence
Group V: Sequence BExperimental Treatment3 Interventions
Three period alternative intervention and fed/fasted sequence
Group VI: Sequence AExperimental Treatment3 Interventions
Three period alternative intervention and fed/fasted sequence
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
K-877-ER
2023
Completed Phase 1
~30
K-001
2023
Completed Phase 1
~50
CSG452
2023
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor
44 Previous Clinical Trials
16,390 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants over three decades of age being accepted into this research?

"In keeping with the enrollment criteria of this research, prospective participants must be between 18 and 45 years old."

Answered by AI

Has the FDA sanctioned Sequence A for clinical use?

"Sequence A has a safety score of 1 due to the limited efficacy and safety data collected in Phase 1 testing."

Answered by AI

Are researchers currently accepting applications for this medical experiment?

"The clinical trial is in search of applicants, as seen on clinicaltrials.gov; it was initially posted on February 23rd 2023 and has been recently revised on the 21st of that same month."

Answered by AI

What is the aggregate enrollment of participants in this trial?

"Confirmed. According to clinicaltrials.gov, this study is actively seeking 30 participants from a single medical centre. The trial was first posted on February 23rd 2023 and the information has been revised as recently as February 21st 2023."

Answered by AI

Do I satisfy all of the prerequisites to partake in this trial?

"This research seeks 30 subjects aged 18 to 45 who are in general good health. To qualify, individuals must provide written consent and have a BMI between 18-30kg/m2 while satisfying all other criteria mentioned within the study protocol."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
PPD - Austin Research Unit
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452
2023. "Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05722262.
~14 spots leftby Apr 2025
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