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

Part of paid clinical trials in Austin, Texas.

Sponsor
CTI BioPharma
Study ID
NCT05657613
Phase
PHASE1
Status
Completed

Conditions

  • Drug Interactions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • CYP450 Cocktail and Transporter Substrates with Pacritinib — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

This is a Phase 1, open-label, fixed-sequence, 2-part DDI study. Subjects will participate in only 1 study part.

Key Dates

Start date
Jan 3, 2023
Status verified
Oct 2024
Primary completion
Jun 8, 2023
Completion
Jun 8, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CYP450 Cocktail and Transporter Substrates with Pacritinib
    This is the first part of the study which is an open-label, single-center, 1-way DDI study designed to assess the effect of pacritinib 200 mg BID at steady state on the systemic exposure of a cocktail of cytochrome P450 (caffeine, midazolam, and omeprazole) and transporter substrates (digoxin, rosuvastatin, and metformin) in 18 healthy male subjects.
  • Experimental: CYP450 3A4 inducer (Bosentan) with Pacritinib
    The second part of the study comprises of 2 arms. This is the first arm Days 1 through 14: An oral dose of pacritinib 200 mg (2 × 100 mg capsules) BID (approximately 12 hours apart) Days 8 through 14: An oral dose of bosentan 125 mg BID (approximately 12 hours apart) All the doses will be administered with approximately 240 mL of water.
  • Experimental: CYP450 3A4 inhibitor (Fluconazole) with Pacritinib
    This is the second arm of Part 2 of the study: Days 1 through 14: An oral dose of pacritinib 200 mg (2 × 100 mg capsules) BID (approximately 12 hours apart) Days 8 through 14: An oral dose of fluconazole 200 mg QD

Primary Outcome Measure

Change in area under curve (AUC) of individual substrates between cocktail alone and cocktail combined with pacritinib administration [ Time Frame: Through study completion, a maximum of 14 days for pacritinib ]

Locations (1)

FacilityCityStateZIPSite coordinators
Site 1AustinTexas78744-

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By research site
Site 1· Austin, TX

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