NCT02590289

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fresh Tracks Therapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	BBI-5000	BBI-5000 low dose, middle dose, or high doses

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-10-29
• Last updated: 2023-01-19

Locations

1 site across 1 country: United States