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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01348724
First received: April 21, 2011
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: [14C] NKTR-118
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Concentration of total radioactivity in blood and plasma samples [ Time Frame: Range of Day 1 until day 10 ] [ Designated as safety issue: No ]
  • Concentration of NKTR-118 in blood and plasma sample [ Time Frame: Range of Day 1 until day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [14C] NKTR-118 Drug: [14C] NKTR-118
Single 25 mg oral dose administered on Day 1

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348724

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Marianne Kasti, MD Quintiles
Study Director: Mark Sostek, PhD AstraZeneca
Study Chair: Emeline Ramos AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01348724     History of Changes
Other Study ID Numbers: D3820C00001
Study First Received: April 21, 2011
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Radioactive carbon
Absorption
Distribution
Metabolism
Excretion
Healthy Volunteers

ClinicalTrials.gov processed this record on April 23, 2014