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

NCT ID: NCT04908800

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2022-04-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A single ascending dose (SAD) and Part B multiple ascending dose (MAD): KRP-A218

Administration Route: Oral

Group Type: EXPERIMENTAL

KRP-A218

Intervention Type: DRUG

KRP-A218 tablet

Part A (SAD) and Part B (MAD): Placebo

Administration Route: Oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet

Part C drug-drug interaction (DDI): KRP-A218 and itraconazole

Administration Route: Oral

Group Type: EXPERIMENTAL

KRP-A218

Intervention Type: DRUG

KRP-A218 tablet

itraconazole

Intervention Type: DRUG

10 mg/mL oral solution

Interventions

KRP-A218

KRP-A218 tablet

Intervention Type: DRUG

Placebo

Placebo tablet

Intervention Type: DRUG

itraconazole

10 mg/mL oral solution

Intervention Type: DRUG

Other Intervention Names

Sporanox

Eligibility Criteria

Inclusion Criteria

• Male or female adults, between 20 and 55 years of age, inclusive.
• Body weight ≥50 kg, with body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
• In good health, at Screening or Day -1 as assessed by the Investigator.
• Females will not be pregnant or lactating, and females of childbearing potential will agree to use contraception and to not donate eggs (ova, oocytes). Males will agree to use contraception and to not donate sperm.
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Exclusion Criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing.
• Use or intend to use any prescription medications/products within 14 days or 5 half-lives (whichever is longer) prior to dosing, unless deemed acceptable by the Investigator.
• Use or intend to use slow release medications/products considered to still be active within 14 days prior to dosing, unless deemed acceptable by the Investigator.
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to dosing, unless deemed acceptable by the Investigator.
• Use of tobacco or nicotine-containing products within 3 months prior to Day -1, or positive cotinine test at screening or Day -1.
• Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to Day -1.
• Consumption of caffeine- or xanthine-containing foods and beverages within 36 hours prior to Day -1.
• Participation in strenuous exercised within 7 days prior to Day -1.
• Receipt of blood products within 2 months prior to Day -1.
• Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
• Poor peripheral venous access.
• Have previously completed or withdrawn from this study or have previously received the investigational medicinal product (IMP).
• Subject is, in the opinion of the Investigator, unlikely to comply with the protocol or unsuitable to participate in this study for any reason.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyorin Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoji Mimaki

Role: STUDY_CHAIR

Kyorin Pharmaceutical Co.,Ltd

Locations

Labcorp Clinical Research

Leeds, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

KRPA218-T101

Identifier Type: -

Identifier Source: org_study_id