Phase 1
Completed N=70
Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)
Source: ClinicalTrials.gov NCT03336502 ↗Enrolled (actual)
70
Serious AEs
21.4%
Results posted
Dec 2019
Primary outcomePrimary: Steady State (ss) Average Concentration (Cavg) of Posaconazole of Serial PK (Subgroup 1) on Day 10 — 2986.28 ng/mL
Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of posaconazole intravenous solution in Chinese participants at high risk for invasive fungal infections. Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes will be enrolled in the study. The primary hypothesis is to evaluate the pharmacokinetic parameters of intravenous (IV) posaconazole (POS) solution in Chinese participants at high risk of invasive fungal infections and determine the percentage of Chinese participants who reach steady-state concentration averages of POS in blood plasma of 500 ng/ml and higher. Two subgroups were evaluated: Subgroup 1 from serial PK blood draw sampling and Subgroup 2 from sparse limited PK blood draw sampling.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady State (ss) Average Concentration (Cavg) of Posaconazole of Serial PK (Subgroup 1) on Day 10 |
2986.28 | — |
| PRIMARY Percentage of Participants With ssCavg ≥500 ng/mL of Serial PK (Subgroup 1) on Day 10 |
40.7; 33.3; 25.9 | — |
| PRIMARY Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of POS of Serial PK (Subgroup 1) on Day 10 |
71670.8 | — |
| PRIMARY Steady State Maximum Concentration (ssCmax) of POS of Serial PK (Subgroup 1) on Day 10 |
4612.22 | — |
| PRIMARY Steady State Minimum Concentration (ssCmin) of POS of Serial PK (Subgroup 1) on Day 10 |
2311.33 | — |
| PRIMARY Time to Steady-state Maximum Concentration (ssTmax) of POS of Serial PK (Subgroup 1) on Day 10 |
1.63 | — |
| PRIMARY Total Body Clearance (CL) of POS of Serial PK (Subgroup 1) on Day 10 |
4767.90 | — |
| PRIMARY POS Plasma Trough Concentrations in the Serial PK and Sparse PK Subgroups |
1800.93; 2033; 2106.07; 2514; 2473.78; 2466 | — |
| SECONDARY Adverse Events (AEs) |
70 | — |
| SECONDARY Discontinuations Due to an AE |
9 | — |
| SECONDARY Medically Significant Changes in Clinical Laboratory Results - Lab Values |
30; 35 | — |
| SECONDARY Medically Significant Changes in Clinical Laboratory Results - Vital Signs |
27; 31 | — |
| SECONDARY Survival Status |
64; 6 | — |
| SECONDARY Participants With Invasive Fungal Infection (IFI) |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Chinese participant
- Female of reproductive potential with a serum of beta human chorionic gonadotropin (β-hCG) level consistent with a nongravid state and agree and/or have their partner use 2 acceptable methods of birth control throughout the study
- Body Mass Index (BMI) >=15 and 2 prior to induction chemotherapy for the underlying disease
- Known or suspected Gilbert's disease.
Data sourced from ClinicalTrials.gov (NCT03336502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.