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

NCT ID: NCT03880487

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2020-04-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

KP-1199

Group Type: EXPERIMENTAL

KP-1199

Intervention Type: DRUG

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

Placebo oral capsules

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

Oxycodone oral capsules

Group Type: ACTIVE_COMPARATOR

Oxycodone oral capsule

Intervention Type: DRUG

10 mg Oxycodone Capsules

Interventions

KP-1199

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

Intervention Type: DRUG

Placebo oral capsule

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

Intervention Type: DRUG

Oxycodone oral capsule

10 mg Oxycodone Capsules

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

PRA Health Sciences

INDUSTRY

Sponsor Role: collaborator

Kalyra Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Bunker, PhD

Role: STUDY_DIRECTOR

Kalyra Pharmaceuticals, Inc.

Locations

PRA Health Sciences

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

CDMRP-OR 160158

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KP-1199-CP-001

Identifier Type: -

Identifier Source: org_study_id