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Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118

NCT01533155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2014-10-15

No results posted yet for this study

Summary

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

Conditions

  • Drug Induced Constipation

Interventions

DRUG

Nektar 118

Oral 25 mg tablet

DRUG

Quinidine

Oral 200 mg tablet

DRUG

Quinidine placebo

Oral Tablet

DRUG

Morphine

10 mg/ml, intravenously

Sponsors & Collaborators

Principal Investigators

  • Phil Leese, MD · Quintiles Kansas United states

  • Mark Sostek, MD · Astrazeneca, Wilmington US

  • Bo Fransson, MD · Astrazeneca, Sodertalje Sweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01533155 on ClinicalTrials.gov