Overview

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

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
Summary
Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of NKTR-118.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Treatments:
Naloxegol
Rifampin
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.