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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014