Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics of NKTR-118

Study identifier:D3820C00011

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, 2-Part, Crossover, Single Center Study to Evaluate Effect of Quinidine on the Pharmacokinetics of NKTR-118 and the Concomitant Effect of Quinidine and NKTR-118 on Morphine-induced Miosis

Medical condition

Drug induced constipation

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Nektar 118, Nektar 118, Nektar 118, Nektar 118, Quinidine, Quinidine, Quinidine placebo, Quinidine placebo, Morphine, Morphine

Sex

All

Actual enrollment

214

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Mar 2012
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Sept 2012

Study design

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

Verification:

Verified 01 Oct 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria