Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.

Official Title
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An Open-label, Single-center Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function Following Administration of a Single Dose of 25mg NKTR-118

Conditions
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Hepatic; Functional Disturbance

Intervention / Treatment
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* Drug: NKTR-118


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18 years or more with a weight of at least 50 kg and BMI between 18 and 40 kg/m2, inclusive. Negative screen for human immunodeficiency virus (HIV) For subjects with normal hepatic function, negative results for serum hepatitis B (HBV) surface antigen, HCV antibody, and HIV Exclusion Criteria: Plasma or blood product donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity Known or suspected history of drug/chemical abuse within the past 2 years as judged by the Investigator. Subjects with a history of surgery on the gastrointestinal tract. For patients with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Normal hepatic function, 25 mg NKTR-118 administered orally | Drug: NKTR-118<br>* 25 mg Oral tablets, single dose<br>|
| Experimental: Group 2<br>Mild hepatic impairment, 25 mg NKTR-118 administered orally | Drug: NKTR-118<br>* 25 mg Oral tablets, single dose<br>|
| Experimental: Group 3<br>Moderate hepatic impairment, 25 mg NKTR-118 administered orally | Drug: NKTR-118<br>* 25 mg Oral tablets, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) |  | Duration from predose day 1 to day 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting adverse events. |  | Duration from day -1 to follow up. ( Approximately 15-18 days) | 
| To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting vital signs |  | Duration from day -1 to follow up. ( Approximately 15-18 days) | 
| To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function by collecting safety blood samples |  | Duration from day -1 to follow up. ( Approximately 15-18 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, volunteers with hepatic impairment, pharmacokinetics, NKTR-118, Child-Pugh scale, AUC, Cmax, tmax, t1/2