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

Use our guide to learn which trials are right for you!

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.
We found this trial at
1
site
?
mi
from
Kansas City, KS
Click here to add this to my saved trials