Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:March 2012
End Date:June 2012
Contact:AstraZeneca Clinical Study Information
Email:information.center@astrazeneca.com
Phone:800-236-9933

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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


Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics
of NKTR-118


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

Inclusion Criteria:

- Provision of signed and dated, written informed consent prior to any study-specific
procedures.

- 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 disease or disorder (eg, cardiovascular, pulmonary,
gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine) which, may
put the volunteer at risk of participation in the study, or influence of the ADME of
drugs.

- 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.
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