Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118
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
1 other identifier
interventional
6
1 country
1
Brief Summary
Study to Assess the Absorption, Metabolism and Excretion of \[14C\] NKTR-118 after a Single-Dose Oral Administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 15, 2014
October 1, 2014
3 months
April 21, 2011
October 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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)
Study Arms (1)
[14C] NKTR-118
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London, United Kingdom
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Kasti, MD
Quintiles, Inc.
- STUDY DIRECTOR
Mark Sostek, PhD
AstraZeneca
- STUDY CHAIR
Emeline Ramos
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
May 5, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 15, 2014
Record last verified: 2014-10