NCT03237988

Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects

A Phase 1, Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Corvus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety, and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on single oral doses of CPI-444 tablets in healthy male and female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	CPI-444 Capsules	100mg Capsule
DRUG	CPI-444 Tablets	100mg Tablets

Timeline

• Start date: 2017-07-20
• Primary completion: 2017-09-20
• Completion: 2017-10-04
• First posted: 2017-08-03
• Last updated: 2018-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study