Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.

Detailed Description
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A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 following single and multiple ascending oral dose administration in healthy young and elderly Japanese subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics after single oral doses of NKTR-118 in healthy male Japanese subjects

Official Title
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A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 Following Single and Multiple Ascending Oral Dose Administration in Healthy Young and Elderly Japanese Subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics After Single Oral Doses of NKTR-118 in Healthy Male Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: NKTR-118
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 Years to 45 Years, 65 Years to 80 Years Body mass index (BMI): 18 to 27 kg/m Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product. Non-smokers or ex-smokers (not smoked in the past 3 months). Exclusion Criteria: Clinically relevant disease and/or abnormalities (past or present) Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis as judged by the investigator Use of any prescribed or non-prescribed medication including herbal remedies, vitamins and minerals during the two weeks prior to the first administration of investigational product

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NKTR-118<br> | Drug: NKTR-118<br>* Tablet, Oral, Once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablet, Oral, Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of drug concentrations in plasma by characterizing PK parameters (AUC) |  |  | 
| Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Japan, SAD, MAD