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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-OR 160158 | Other Grant/Funding Number | Department of Defense |
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The Study was terminated early by sponsor
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| PRA Health Sciences | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KP-1199 | Experimental |
| |
| Placebo oral capsules | Placebo Comparator |
| |
| Oxycodone oral capsules | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP-1199 | Drug | Single dose and Multiple ascending doses of KP-1199 oral capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 11, Part 3: From Day 1 through Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199 | Maximum Observed Plasma Concentration (Cmax) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Bunker, PhD | Kalyra Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Salt Lake City | Utah | 84124 | United States |
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| Placebo oral capsule |
| Drug |
Single dose and Multiple dose identical to active treatment but without KP-1199. |
|
| Oxycodone oral capsule | Drug | 10 mg Oxycodone Capsules |
|
Time to Maximum Plasma Concentration (Tmax) |
| 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) | 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) | 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 the trough plasma concentration of KP-1199 | Trough Plasma Concentration (Ctrough) | 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) | 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) | 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)" | 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) | Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration) |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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