Bioavailability, Drug- Drug Interactions, Healthy Volunteers
Conditions
Keywords
Phase 1, Healthy male and female volunteers, Drug-drug interaction, Pharmacokinetics, NKTR-118
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
Interventions
DRUGNKTR-118
Oral 25 mg
DRUGKetoconazole
Oral 400 mg
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of the pharmacokinetic(PK) profile for NKTR 118 after co administration of Ketaconazole in terms of maximum observed plasma concentration (Cmax), time to Cmax (tmax), apparent terminal half-life (t1/2?z). | Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 7 |
| Description of the PK profile for NKTR 118 in terms of apparent terminal rate constant (?z), area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)]. | Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 7 |
| Description of the PK profile for NKTR 118 in terms of area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0 24)], area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC | Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 7 |
| Description of the PK profile for NKTR 118 in terms of apparent oral clearance from plasma (CL/F), and apparent volume of distribution during the terminal phase (Vz/F) | Predose and at 0:15, 0:30, 1, 1:30, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours Day 1 and 7 |
Secondary
| Measure | Time frame |
|---|---|
| Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations, electrocardiograms, and Columbia-Suicide Severity Rating scale | From baseline day 1 through to Follow-u (Maximum 21 days) |
Countries
United States
Outcome results
None listed