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

NCT03880487 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: KP-1199-CP-001CDMRP-OR 160158
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Analgesia

Keywords

Phase I, Healthy Adult Participants

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199

  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

  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

  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

  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

  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)

Study Arms (3)

KP-1199

EXPERIMENTAL

Drug: KP-1199

Placebo oral capsules

PLACEBO COMPARATOR

Drug: Placebo oral capsule

Oxycodone oral capsules

ACTIVE COMPARATOR

Drug: Oxycodone oral capsule

Interventions

KP-1199 DRUG

Single dose and Multiple ascending doses of KP-1199 oral capsules

KP-1199

Placebo oral capsule DRUG

Single dose and Multiple dose identical to active treatment but without KP-1199.

Placebo oral capsules

Oxycodone oral capsule DRUG

10 mg Oxycodone Capsules

Oxycodone oral capsules

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Adult 18-45 years of age at time of screening, 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.

You may not qualify if:

• 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.
• History or evidence of significant clinical or psychiatric disorder, condition, or disease that, in the opinion of the Investigator would pose an unacceptable risk to the subject safety or interfere with the study evaluations, procedures, or completion of the study.
• 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.

Sponsors & Collaborators

• Kalyra Pharmaceuticals, Inc.: lead
• United States Department of Defense: collaborator
• PRA Health Sciences: collaborator

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Kevin Bunker, PhD

  Kalyra Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 19, 2019
• Study Start: March 12, 2019
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-02

Locations

US (1)