Study in Healthy Volunteers to Investigate the Effects of Rifampin 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: | May 2012 |
Contact: | AstraZeneca Clinical Study Information |
Email: | information.center@astrazeneca.com |
Phone: | 800-236-9933 |
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
Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics
of NKTR-118.
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.
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.
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