60
Participants
Start Date
January 3, 2023
Primary Completion Date
June 8, 2023
Study Completion Date
June 8, 2023
CYP450 Cocktail and Transporter Substrates with Pacritinib
"Day 1: Single oral dose of a cocktail of cytochrome P450 substrates (caffeine 100 mg, midazolam 2 mg, omeprazole 20 mg and metformin (transporter)~Day 3: Single oral dose of transporter substrates (digoxin 0.25 mg, rosuvastatin 5 mg)~Days 8-22: Oral doses of pacritinib 200 mg BID approximately 12 hours apart~Day 17: Single oral dose of transporter substrates (digoxin 0.25 mg and rosuvastatin 5 mg) will be coadministered with the AM dose of pacritinib 200 mg.~Day 21: Single oral dose of a cocktail of cytochrome P450 substrates (caffeine 100 mg, midazolam 2 mg, and omeprazole 20 mg) along with transporter substrate (metformin 500 mg) will be coadministered with the AM dose of pacritinib 200 mg."
Part 2 -Group A Bosentan 125 mg (CYP450 3A4 inducer) with Pacritinib
"Days 1-7: Oral doses of pacritinib 200 mg BID~Days 8-14: Oral doses of pacritinib 200 mg BID, coadministered with an oral dose of bosentan 125 mg BID"
Part 2 Group B - Fluconazole (CYP450 3A4 inhibitor) with Pacritinib
"Days 1-7: Oral doses of pacritinib 200 mg BID~Days 8-14: Oral doses of pacritinib 200 mg BID, coadministered with an oral dose of fluconazole 200 mg QD."
Site 1, Austin
Lead Sponsor
Collaborators (1)
PPD Development, LP
INDUSTRY
CTI BioPharma
INDUSTRY