A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects

Dermatitis, Atopic Clinical Trial

Official title: An Open-Label, Single-Dose, 4-Way Crossover, Bioavailability Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Food Effect of BBI-5000 Capsules in Healthy Adult Subjects

Status Completed

Clinical Trial Summary

To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.

Clinical Trial Description

This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.

Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period.

PK and PD will be assessed by blood sampling through 72 hours postdose.

Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests. ;

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

• NCT number: NCT02590289
• Study type: Interventional
• Source: Fresh Tracks Therapeutics, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 2015
• Completion date: December 2015