A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)

NCT01667107 | Terminated Phase 4 Results

• 2 other identifiers: 5592-1052012-003140-68
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.

Conditions

Fungal Infection

Outcome Measures

Primary Outcomes (2)

• Time to Reach 90% of the Steady State Serum Concentration of Posaconazole

  Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.

  Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43

• Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum

  Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.

  Up to Day 42

Secondary Outcomes (1)

• Percentage of Participants Who Develop Invasive Fungal Infection

  Up to Day 84

Study Arms (2)

Posaconazole - CF Participants

EXPERIMENTAL

Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.

Drug: Posaconazole; Drug: Calogen®

Posaconazole - Non-CF Participants

EXPERIMENTAL

Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.

Drug: Posaconazole; Drug: Calogen®

Interventions

Posaconazole DRUG

Also known as: SCH056592, MK-5592, Noxafil®

Posaconazole - CF Participants; Posaconazole - Non-CF Participants

Calogen® DRUG

Posaconazole - CF Participants; Posaconazole - Non-CF Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo lung transplantation
• Able to take oral/nasogastric medication
• Females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study.

You may not qualify if:

• Severe liver disease
• Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant
• Treatment with posaconazole within 14 days before transplant
• Breastfeeding

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Mycoses

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 17, 2012
• Study Start: January 23, 2013
• Primary Completion: January 16, 2014
• Study Completion: January 16, 2014
• Last Updated: October 9, 2018
• Results First Posted: January 5, 2015

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share