An Open-label, Sequential, 3-period Study to Assess the Effects of Cimetidine on the Pharmacokinetics of Naloxegol in Healthy Volunteers.
Study identifier:D3820C00036
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, Sequential, 3-period Study to Assess the Effects of Cimetidine on the Pharmacokinetics of Naloxegol in Healthy Volunteers.
Medical condition
Bioavailability,plasma AUC and Cmax, plasma AUC0-t, t1/2λz, and tmax. Drug drug interaction
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Naloxegol, Cimetidine
Sex
All
Actual Enrollment
25
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jun 2013
Estimated Primary Completion Date: 01 Sept 2013
Estimated Study Completion Date: 01 Sept 2013
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: -
Verification:
-
Sponsors
AstraZeneca
Collaborators
N/A
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A Single dose naloxegol 25mg | Drug: Naloxegol Oral 25mg tablet |
| Active Comparator: B Cimetidine 800 mg once daily on Day 3 through 6 | Drug: Cimetidine Oral 800 mg tablet |
| Active Comparator: C Coadministration of 25 mg naloxegol and 800 mg cimetidine will occur on Day 7 with an additional dose of 800 mg cimetidine to be administered in the morning of Day 8. | Drug: Naloxegol Oral 25mg tablet Drug: Cimetidine Oral 800 mg tablet |
Contacts
Investigators
Principal Investigator
Barbara Lomeli
Quintiles Overland Park US
