Status:
COMPLETED
Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118
Lead Sponsor:
AstraZeneca
Conditions:
Bioavailability
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Study in healthy volunteers to investigate the effects of Ketoconazole on the Pharmacokinetics of NKTR-118
Detailed Description
An Open-label, 1-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 in Healthy Subjects
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01520896
Start Date
February 1 2012
End Date
April 1 2012
Last Update
October 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Overland Park, Kansas, United States