Absorption, Distribution, Metabolism and Excretion (ADME) study with single oral administration of [14C] NKTR-118

Study identifier:D3820C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

[14C] NKTR-118

Sex

Male

Actual Enrollment

Study type

Interventional

Age

35 Years - 50 Years

Date

Study Start Date: 01 Jun 2011

Primary Completion Date: 01 Sept 2011

Study Completion Date: 01 Sept 2011

Study design

Allocation: N/A
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Oct 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

London, United Kingdom

Arms	Assigned Interventions
Experimental: [14C] NKTR-118	Drug: [14C] NKTR-118 Single 25 mg oral dose administered on Day 1

Documents available

Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

001-800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Marianne Kasti

QUINTILES