Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 3, 2023

Primary Completion Date

June 8, 2023

Study Completion Date

June 8, 2023

Conditions
Drug Interactions
Interventions
DRUG

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."

DRUG

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"

DRUG

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."

Trial Locations (1)

78744

Site 1, Austin

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

CTI BioPharma

INDUSTRY