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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

NCT03880487 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-09-16

No results posted yet for this study

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

Interventions

DRUG

KP-1199

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

DRUG

Placebo oral capsule

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

DRUG

Oxycodone oral capsule

10 mg Oxycodone Capsules

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • PRA Health Sciences

    collaborator INDUSTRY

  • Kalyra Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin Bunker, PhD · Kalyra Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2020-04-21
Completion
2020-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880487 on ClinicalTrials.gov