Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118
Completed · Phase 1
Conditions studied: Bioavailability, Healthy Volunteers, Drug- Drug Interactions
In brief
Study in healthy volunteers to investigate the effects of Ketoconazole on the Pharmacokinetics of NKTR-118
Key facts
- Study ID
- NCT01520896
- Run by
- AstraZeneca
- People needed
- 22
- Starts
- 2012-02-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2014-10-15
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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