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

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:

Collaborators

N/A

Inclusion and exclusion criteria

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

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Investigators

Principal Investigator

Barbara Lomeli

Quintiles Overland Park US

An Open-label, Sequential, 3-period Study to Assess the Effects of Cimetidine on the Pharmacokinetics of Naloxegol in Healthy Volunteers.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Investigators

Principal Investigator