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

Kalyra Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Analgesia

Treatments

Drug: Oxycodone oral capsule

Drug: KP-1199

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT03880487

CDMRP-OR 160158 (Other Grant/Funding Number)

KP-1199-CP-001

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

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.
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.