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

NCT05657613 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-17

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Buckley · CTI BioPharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2023-06-08
Completion
2023-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657613 on ClinicalTrials.gov