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
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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
