Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118

Study Overview
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Brief Summary
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Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a Single-Dose Oral Administration.

Official Title
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A Phase I, Open-Label, Single-Centre Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After [14C]-Labelled Oral Administration of NKTR-118 to Healthy Male Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C] NKTR-118


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and a minimum weight of 50 kg Regular daily bowel movements (ie, production of at least 1 stool per day). Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥3 months prior to Visit 1 Exclusion Criteria: Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life Participation in any prior radiolabelled study within 12 months of screening visit 1 Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C] NKTR-118<br> | Drug: [14C] NKTR-118<br>* Single 25 mg oral dose administered on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces |  | Range of Day 1 until day 10 | 
| Concentration of total radioactivity in blood and plasma samples |  | Range of Day 1 until day 10 | 
| Concentration of NKTR-118 in blood and plasma sample |  | Range of Day 1 until day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing adverse event |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing vital signs |  | Range of Day -1 until follow up visit (Visit 3) | 
| Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing safety blood samples |  | Range of Day -1 until follow up visit (Visit 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers