MedTrace Logo

Bioavailability of KBP-5074 Tablet vs Capsule Formulations

NCT03340753 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-16

No results posted yet for this study

Summary

This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet formulation versus that of the current capsule formulation. Data derived from this study, in addition to preclinical data and chemistry, manufacturing, and controls, will provide a basis for dose selection in future studies.

Conditions

  • Bioequivalence

Interventions

DRUG

KBP-5074 Capsule

KBP-5074 (0.5 mg or 1.0 mg) capsule formulation single dose, in a 2-period crossover design with a 2-week washout/follow-up period

DRUG

KBP-5074 Tablet

KBP-5074 (0.5 mg or 1.0 mg) tablet formulation single dose, in a 2-period crossover design with a 2-week washout/follow-up period

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • KBP Biosciences

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2017-11-22
Completion
2017-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03340753 on ClinicalTrials.gov