Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects

Study identifier:D3820C00025

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Randomized, Balanced, Single-dose, Two-Part Study to Assess the Relative Bioavailability of NKTR-118 in Three Formulations under Fasted (3-Way crossover) and Fed (2-Way crossover) Conditions in Male and Non-fertile Female Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

NKTR118 Formulation 1, NKTR118 Formulation 1, NKTR118 Formulation 2, NKTR118 Formulation 3, NKTR118 Formulation 1a, NKTR118 Formulation 3a

Sex

All

Actual enrollment

21

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Jun 2011
Primary Completion Date: 01 Aug 2011
Study Completion Date: 01 Aug 2011

Study design

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

Verification:

Verified 01 Oct 2014 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria