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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. ;


Study Design


Related Conditions & MeSH terms


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

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