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, Quinidine, Quinidine placebo, 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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: NKTR-118/ Quinidine One 25-mg NKTR-118 tablet will be administered once with 3 Quinidine 200mg tablets in the morning of period 1 or period 2 (part 1) | Drug: Nektar 118 Oral 25 mg tablet Drug: Quinidine Oral 200 mg tablet |
| Placebo Comparator: NKTR-118/ Placebo One 25-mg NKTR-118 tablet will be administered once with 3 Placebo tablets in the morning of period 1 or period 2 (part 1) | Drug: Nektar 118 Oral 25 mg tablet Drug: Quinidine placebo Oral Tablet |
| Active Comparator: NKTR-118/ Quinidine/ Morphine One 25-mg NKTR-118 tablet will be administered with 3 Quinidine 200mg tablets with Morphine inj 5mg/70kg once in the morning on period 3 or period 4 (Part 2) | Drug: Nektar 118 Oral 25 mg tablet Drug: Quinidine Oral 200 mg tablet Drug: Quinidine placebo Oral Tablet Drug: Morphine 10 mg/ml, intravenously |
| Placebo Comparator: NKTR-118/ Placebo/ Morphine One 25-mg NKTR-118 tablet will be administered with 3 placebo tables with Morphine inj 5mg/70kg once in the morning of period 3 or period 4 (part 2) | Drug: Nektar 118 Oral 25 mg tablet Drug: Morphine 10 mg/ml, intravenously |
Contacts
Contact Backup
Quintiles Overland Park, Volunterer Recruitment
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-
Investigators
Principal Investigator
Phil Leese
Quintiles Kansas United states
