An Open-label, Single-dose Study for the Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of KP-001
Overview
- Phase
- Phase 1
- Intervention
- KP-001
- Conditions
- Healthy Adults
- Sponsor
- Kaken Pharmaceutical
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- PK parameters of KP-001 in plasma: Cmax
- Status
- Completed
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •・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-
Exclusion Criteria
- •・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.
Arms & Interventions
Cohort1 (Normal)
Child-Pugh Score: N/A
Intervention: KP-001
Cohort2 (Mild Impairment)
Child-Pugh Score: A (5 to 6 points)
Intervention: KP-001
Cohort3 (Moderate Impairment)
Child-Pugh Score: B (7 to 9 points)
Intervention: KP-001
Cohort4 (Severe Impairment)
Child-Pugh Score: C (10 to 15 points)
Intervention: KP-001
Outcomes
Primary Outcomes
PK parameters of KP-001 in plasma: Cmax
Time Frame: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
To evaluate the effect of hepatic impairment on the PK and safety of KP-001
PK parameters of KP-001 in plasma:AUC0-inf
Time Frame: pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
To evaluate the effect of hepatic impairment on the PK and safety of KP-001
Secondary Outcomes
- 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)
- PK parameters of KP-001 in plasma: Tmax(pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose)