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A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199

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ClinicalTrials.gov Identifier: NCT03880487
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
United States Department of Defense
PRA Health Sciences
Information provided by (Responsible Party):
Kalyra Pharmaceuticals, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Analgesia Drug: KP-1199 Drug: Placebo oral capsule Drug: Oxycodone oral capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

Arm Intervention/treatment
Experimental: KP-1199 Drug: KP-1199
Single dose and Multiple ascending doses of KP-1199 oral capsules

Placebo Comparator: Placebo oral capsules Drug: Placebo oral capsule
Single dose and Multiple dose identical to active treatment but without KP-1199.

Active Comparator: Oxycodone oral capsules Drug: Oxycodone oral capsule
10 mg Oxycodone Capsules




Primary Outcome Measures :
  1. Number of Participants with Treatment Emergent Adverse Events [ Time Frame: Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 10, Part 3: From Day 1 through Day 11 ]
    Number of treatment related adverse events as determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters


Secondary Outcome Measures :
  1. Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199 [ Time Frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 7), Part 3: (pre-dose through Day 7) ]
    Maximum Observed Plasma Concentration (Cmax)

  2. Pharmacokinetic Profile of KP-1199 to measure Time to Maximum plasma concentration of KP-1199 [ Time Frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 7), Part 3: (pre-dose through Day 7) ]
    Time to Maximum Plasma Concentration (Tmax)

  3. Pharmacokinetic Profile of KP-1199 to measure area under curve plasma concentration of KP-1199 [ Time Frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 7), Part 3: (pre-dose through Day 7) ]
    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)

  4. Pharmacokinetic Profile of KP-1199 to measure plasma terminal half-life concentration of KP-1199 [ Time Frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 7), Part 3: (pre-dose through Day 7) ]
    The Apparent Terminal Elimination Half-life (t1/2)

  5. Pharmacokinetic Profile of KP-1199 to measure the trough plasma concentration of KP-1199 [ Time Frame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 7), Part 3: (pre-dose through Day 7) ]
    Trough Plasma Concentration (Ctrough)

  6. Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain threshold [ Time Frame: Part 1: Day 1 (pre-dose through 3 hours after dose adminstration), Part 2: Day 4 (at 3 hours post morning dose) and Day 6 (at 3 and 6 hours post last dose), Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration) ]
    Time to feel first pain ("pain threshold" measured in seconds)

  7. Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain tolerance [ Time Frame: Part 1: Day 1 (pre-dose through 3 hours after dose adminstration), Part 2: Day 4 (at 3 hours post morning dose) and Day 6 (at 3 and 6 hours post last dose, Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration) ]
    Time to withdrawal of hand from cold water ("Pain tolerance" in seconds)

  8. Pharmacodynamic Effects of KP-1199 using Cold Pressor Test [ Time Frame: Part 1: Day 1 (pre-dose through 3 hours after dose adminstration), Part 2: Day 4 (at 3 hours post morning dose) and Day 6 (at 3 and 6 hours post last dose), Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration) ]
    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)"

  9. Pharmacodynamic Effects of KP-1199 using Ultraviolet Burn Model (UVB) [ Time Frame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration) ]
    Neurosensory Testing (change in neurosensory assessments of the skin at site of ultraviolet burn)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Adult 18-45 years of age, inclusive.
  • Have a body mass index (BMI) between 18.0 and ≤32 kg/m2, inclusive, and a weight of ≥50 kg at screening.
  • Be determined to be healthy on the basis of a pre-study physical examination, medical history review, vital sign measurements, and the results of laboratory tests.
  • For both male and females: using acceptable method of birth control
  • If Female: not-pregnant or not breast feeding and not planning on becoming pregnant
  • All prescribed medication must have been stopped at least 14 days prior to admission to the clinical research site. An exception is made for hormonal contraceptives, which may be used throughout the study.
  • All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research site.
  • Must be adequately informed and understand the nature and risks of the study and must provide written informed consent prior to enrollment at screening.

Exclusion Criteria:

  • Subjects who participate in one part of the study are not eligible to participate in subsequent parts of the study.
  • Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
  • Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
  • Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects.
  • Documented congenital QT syndrome, and/or corrected QT interval (Fridericia correction; QTcF) at screening or first admission > 450 ms.
  • Positive screening test for hepatitis B surface antigen, anti-hepatitis C virus antibodies or anti-human immunodeficiency virus 1 and 2 antibodies.
  • History of drug allergy diagnosed by a physician.
  • Use of tobacco within 30 days prior to the first study drug administration.
  • History of alcohol consumption exceeding 2 standard drinks per day on average.
  • Routine or chronic use of more than 0.5 grams of acetaminophen daily.
  • History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research site or planned donation before 30 days has elapsed since intake of study drug.
  • Plasma or platelet donation within 7 days of dosing
  • Use of any investigational drug or device within 30 days of the first dose of study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880487


Contacts
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Contact: Brian F Kenney 8582634333 info@kalyrapharma.com

Locations
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United States, Utah
PRA Health Sciences Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Sam Mackin         
Sponsors and Collaborators
Kalyra Pharmaceuticals, Inc.
United States Department of Defense
PRA Health Sciences
Investigators
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Study Director: Kevin Bunker, PhD Kalyra Pharmaceuticals, Inc.

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Responsible Party: Kalyra Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03880487     History of Changes
Other Study ID Numbers: KP-1199-CP-001
CDMRP-OR 160158 ( Other Grant/Funding Number: Department of Defense )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kalyra Pharmaceuticals, Inc.:
Phase I, Healthy Adult Participants

Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents