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

October 13, 2014 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Range of Day 1 until day 10
Range of Day 1 until day 10
Concentration of total radioactivity in blood and plasma samples
Time Frame: Range of Day 1 until day 10
Range of Day 1 until day 10
Concentration of NKTR-118 in blood and plasma sample
Time Frame: Range of Day 1 until day 10
Range of Day 1 until day 10

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Marianne Kasti, MD, Quintiles, Inc.
  • Study Director: Mark Sostek, PhD, AstraZeneca
  • Study Chair: Emeline Ramos, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 13, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3820C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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