A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001

NCT06619054 | Completed Phase 1 FDA Drug

• 1 other identifier: KP-001-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1, open-label, non-randomized, parallel-group, single-dose study to assess the effect of hepatic impairment (assessed by the criteria of the Child-Pugh scale) on the pharmacokinetics (PK) and safety of KP-001 in adult male and non-childbearing potential female participants aged ≥20 years old. The purpose of this study is to evaluate the effect of hepatic impairment on the PK and safety of KP-001. The study will also assess the effect of hepatic impairment on other PK parameters after single dose administration of KP-001. The study will comprise 3 parts, and the study period for each part will consist of the following:

• Screening period: Up to 28 days before the administration of study intervention
• Treatment Period: Participants will be residential at the Clinical Unit from the day before the administration of the single dose of KP-001 (Day -1) until Day 3 (Discharge)
• Follow-up Visit: 7 days after discharge from the Clinical Unit (ie, Day 10) Participants will be enrolled into 4 cohorts according to the hepatic function status as summarized below. The study includes a control group of healthy participants with normal hepatic function.

Conditions

Healthy Adults; Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• PK parameters of KP-001 in plasma: Cmax

  To evaluate the effect of hepatic impairment on the PK and safety of KP-001

  pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

• PK parameters of KP-001 in plasma:AUC0-inf

  To evaluate the effect of hepatic impairment on the PK and safety of KP-001

  pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Secondary Outcomes (6)

• PK parameters of KP-001 in plasma: AUC0-last

  pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

• PK parameters of KP-001 in plasma: t1/2

  pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

• PK parameters of KP-001 in plasma: λz

  pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

• PK parameters of KP-001 in plasma: CL/F

  pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

• PK parameters of KP-001 in plasma: Vz/F

  pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Study Arms (4)

Cohort1 (Normal)

EXPERIMENTAL

Child-Pugh Score: N/A

Drug: KP-001

Cohort2 (Mild Impairment)

EXPERIMENTAL

Child-Pugh Score: A (5 to 6 points)

Drug: KP-001

Cohort3 (Moderate Impairment)

EXPERIMENTAL

Child-Pugh Score: B (7 to 9 points)

Drug: KP-001

Cohort4 (Severe Impairment)

EXPERIMENTAL

Child-Pugh Score: C (10 to 15 points)

Drug: KP-001

Interventions

KP-001 DRUG

Oral single dose 50mg.

Cohort1 (Normal); Cohort2 (Mild Impairment); Cohort3 (Moderate Impairment); Cohort4 (Severe Impairment)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ・All Participants (Cohorts 1 to 4)
• Participant is male or female and aged ≥20 years old at the time of signing the informed consent.
• Participant has body weight ≥40.0 kg and body mass index between 18.0 and 42.0 kg/m2 at screening.
• Female participant is a woman of non-childbearing potential who:
• Is postmenopausal with amenorrhea for at least 1 year prior to screening and with FSH of 40 IU/L or higher.
• Has undergone one of the following:
• bilateral tubal ligation or bilateral salpingectomy
• hysterectomy
• bilateral oophorectomy
• Male participant who is sexually active with female partner(s) of childbearing potential must agree to use both a condom and spermicide from the day of the administration of KP-001 until 91 days after the administration of KP-001.
• Male participant must agree to not donate sperm from the day of the administration of KP-001 until 91 days after the administration of KP-001.
• Participant is capable of giving signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• ・Healthy Participants with Normal Hepatic Function (Cohort 1)
• Participant is of a gender matched to his/her matched participant enrolled in Cohort 3.
• Participant is of an age that is within ±10 years to his/her matched participant enrolled in Cohort 3.

You may not qualify if:

• ・All Participants (Cohorts 1 to 4)
• Participant has a history or presence of hypersensitivity or idiosyncratic reaction to any components of the KP-001 formulation or any components of formulation used as study intervention during the study.
• Participant has a complication of drug allergies or history of drug allergies, or psychiatric disorder as determined by the Investigator or designee.
• Participant used any investigational drug in the last 30 days or 5 half-lives (if known), whichever is longer, prior to Day -1 of Treatment Period.
• Female participant has a positive pregnancy test or is lactating.
• Participant has positive urine drug or urine alcohol and positive cotinine test results at screening or Day -1 of Treatment Period.
• Participant who cannot administer drugs orally.
• Participant is unable or unwilling to undergo multiple venipunctures.
• Participant underwent blood donation or transfusion within 56 days prior to Day -1 of Treatment Period.
• Participant has consumed alcohol- or caffeine-containing foods and beverages within 72 hours prior to Day -1 of Treatment Period and does not agree to refrain from consuming during the entire study, unless deemed acceptable by the Investigator.
• Participant has consumed grapefruit-containing foods and beverages within 7 days prior to Day -1 of Treatment Period and does not agree to refrain from consuming during the entire study.
• Participant has consumed St. John's wort-containing foods and beverages within 14 days prior to Day -1 of Treatment Period and does not agree to refrain from consuming during the entire study.
• Participated in strenuous exercise from 48 hours prior to Check-in (Day -1) or during the study through the final end of study assessment.
• Participant is legally, mentally or physically incapacitated or, in the opinion of the Investigator, has significant mental or emotional problems, including psychiatric illness (e.g., depression and/or anxiety) at the time of the Screening Visit, or that could reasonably be expected to develop during the conduct of the study.
• Participant had any laboratory abnormality that, in the judgment of the Investigator, would put the participant at unacceptable risk for participation in the study or may interfere with the assessments included in the study.

Sponsors & Collaborators

• Kaken Pharmaceutical: lead

Study Sites (1)

Sites contracted by Parexel

San Antonio, Texas, 08103, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 1, 2024
• Study Start: October 24, 2024
• Primary Completion: May 16, 2025
• Study Completion: July 31, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)