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An Open-label, Fixed-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Rifampin on Pharmacokinetics of NKTR-118 in Healthy Subjects

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Conditions:		Drug Induced Constipation
Purpose:		Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of NKTR-118.
Study Summary:		An Open-label, fixed-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Rifampin on Pharmacokinetics of NKTR-118 in Healthy Subjects.
Criteria:		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 have a negative pregnancy test at screening and at admission, must not be lactating, and must be of nonchildbearing potential. - 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, metabolic, malignant, psychiatric, or major physical impairment), as judged by the Investigator. - Any clinically significant illness, medical/surgical procedure or trauma, in the opinion of the Investigator, 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. - Significant orthostatic reaction at enrollment as judged by the Investigator. - Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
NCT ID:		NCT01533870
Primary Contact:		Study Chair Bo Fransson, MD AstraZeneca, Sodertalje Sweden
Backup Contact:		N/A
Location Contact:		Overland Park, Kansas United States There is no listed contact information for this specific location. Site Status: N/A

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