MedTrace Logo

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects

NCT04908800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-01-08

Study results available
· View outcomes & findings →

Summary

This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect. In Part C, the drug-drug interaction (DDI) with itraconazole will be evaluated.

Conditions

  • Healthy

Interventions

DRUG

KRP-A218

KRP-A218 tablet

DRUG

Placebo

Placebo tablet

DRUG

itraconazole

10 mg/mL oral solution

Sponsors & Collaborators

  • Kyorin Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Yoji Mimaki · Kyorin Pharmaceutical Co.,Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2022-04-21
Completion
2022-04-21

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04908800 on ClinicalTrials.gov