Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118
NCT ID: NCT01533155
Last Updated: 2014-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
214 participants
INTERVENTIONAL
2012-03-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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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)
Nektar 118
Oral 25 mg tablet
Quinidine
Oral 200 mg tablet
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)
Nektar 118
Oral 25 mg tablet
Quinidine placebo
Oral Tablet
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)
Nektar 118
Oral 25 mg tablet
Quinidine
Oral 200 mg tablet
Quinidine placebo
Oral Tablet
Morphine
10 mg/ml, intravenously
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)
Nektar 118
Oral 25 mg tablet
Morphine
10 mg/ml, intravenously
Interventions
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Nektar 118
Oral 25 mg tablet
Quinidine
Oral 200 mg tablet
Quinidine placebo
Oral Tablet
Morphine
10 mg/ml, intravenously
Eligibility Criteria
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Inclusion Criteria
* Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
* Female volunteers must be nonpregnant and nonlactating. Women of childbearing potential must have negative pregnancy test (screening and admission) and be using a highly-effective form of birth control for 3 months before enrollment.
* Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
* Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.
Exclusion Criteria
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP.
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
* History (personal or family) of torsades de pointes, any other polymorphic ventricular tachycardia, long QT syndrome, sudden death or Brugada syndrome, or personal history of sustained (greater than 30 s) monomorphic ventricular tachycardia.
* Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
18 Years
55 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Phil Leese, MD
Role: PRINCIPAL_INVESTIGATOR
Quintiles Kansas United states
Mark Sostek, MD
Role: STUDY_DIRECTOR
Astrazeneca, Wilmington US
Bo Fransson, MD
Role: STUDY_CHAIR
Astrazeneca, Sodertalje Sweden
Locations
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Research Site
Overland Park, Kansas, United States
Countries
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Related Links
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Clinical\_Study\_Report\_Synopsis\_D3820C00011
Other Identifiers
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D3820C00011
Identifier Type: -
Identifier Source: org_study_id
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