This is a Phase I, randomized, placebo and active-controlled, double blind, single and multiple ascending dose study in healthy adults to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KP-1199
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
Single dose and Multiple ascending doses of KP-1199 oral capsules
Single dose and Multiple dose identical to active treatment but without KP-1199.
10 mg Oxycodone Capsules
PRA Health Sciences
Salt Lake City, Utah, United States
Number of Participants with Treatment Emergent Adverse Events
Number of treatment related adverse events as determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters
Time frame: Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 11, Part 3: From Day 1 through Day 12
Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199
Maximum Observed Plasma Concentration (Cmax)
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure Time to Maximum plasma concentration of KP-1199
Time to Maximum Plasma Concentration (Tmax)
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure area under curve plasma concentration of KP-1199
Area Under the Concentration-time Curve Up to Time (t), where t is the last point with concentrations above the lower limit of quantitation (AUC0-t) Area Under the Concentration-time Curve for 1 dosing interval of a multiple dose regimen (AUCtau)
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacokinetic Profile of KP-1199 to measure plasma terminal half-life concentration of KP-1199
The Apparent Terminal Elimination Half-life (t1/2)
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
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Pharmacokinetic Profile of KP-1199 to measure the trough plasma concentration of KP-1199
Trough Plasma Concentration (Ctrough)
Time frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain threshold
Time to feel first pain ("pain threshold" measured in seconds)
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain tolerance
Time to withdrawal of hand from cold water ("Pain tolerance" in seconds)
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Cold Pressor Test
Pain tolerance will be measured at time of hand withdrawal using a 11-point (0-10) Numeric Pain Rating Scale (NPRS) where "0 (no pain) to 10 (worst pain)"
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Pharmacodynamic Effects of KP-1199 using Ultraviolet Burn Model (UVB)
Neurosensory Testing (change in neurosensory assessments of the skin at site of ultraviolet burn)
Time frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)