Phase 1
Completed N=65
Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)
Source: ClinicalTrials.gov NCT02387983 ↗Enrolled (actual)
65
Serious AEs
6.2%
Results posted
Jul 2017
Primary outcomePrimary: Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8 — 0.0; 88.9; 11.1; 0 Percentage of Participants
Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole tablets 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8 |
0.0; 88.9; 11.1; 0 | — |
| PRIMARY Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of Posaconazole on Day 8 |
38600 | — |
| PRIMARY Steady-state Maximum Concentration (ssCmax) of Posaconazole on Day 8 |
2150 | — |
| PRIMARY Steady-state Minimum Concentration (ssCmin) of Posaconazole on Day 8 |
1310 | — |
| PRIMARY Time to Steady-state Maximum Concentration (ssTmax) of Posaconazole on Day 8 |
4.04 | — |
| PRIMARY AUC0-24hr of Posaconazole on Day 1 |
14500 | — |
| PRIMARY Cmax of Posaconazole on Day 1 |
730 | — |
| PRIMARY Cmin of Posaconazole on Day 1 |
997 | — |
| PRIMARY Tmax of Posaconazole on Day 1 |
3.99 | — |
Eligibility Criteria
Inclusion Criteria
- Chinese participant
- Female of reproductive potential with a serum hCG level consistent with a nongravid state and agree to 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 (NCT02387983). 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.