The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
21
Oral dose, 25 mg
Oral dose, 25 mg
Oral dose, 25 mg
Research Site
Overland Park, Kansas, United States
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax)
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax)
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz)
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t))
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC).
Time frame: day-1 to day 3
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing adverse events
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Safety Laboratory values
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing 12-Lead Electrocardiograms
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Columbia-Suicide Severity Rating Scale (C-SSRS)
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Oral dose, 25 mg
Oral dose, 25 mg
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Concentration of NKTR-118 in plasma samples after drug intake during Fed condition
Time frame: Duration: Day 1 to day 4 at the 2 last inhouse stays