Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend)

A Randomized, Open-label, Two-Treatment, Two-Period, Two-Sequence, Cross-over Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend) in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetic properties and safety of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).

Study Overview

• Status: Completed
• Conditions: Systemic Mycotic Infection
• Intervention / Treatment: Drug: SYP-1018 200mg; Drug: Voriconazole 200mg

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Clinical Research Institute, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy adults 20-45 years of age
• Weight of ≥ 60kg ≤ 90kg with BMI of ≥ 19 and < 27 (BMI(kg/m2)= weight(kg)/{height(m)}2
• Voluntary written informed consent

Exclusion Criteria:

• History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
• Drug allergies to Voriconazole
• Recent history or evidence of drug abuse
• Recent participation(within 2 months) in other clinical studies
• Recent donation of blood(within 2months), plasma(within 1month) or transfusion(within 1month)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; SYP-1018 200mg → Voriconazole 200mg	Drug: SYP-1018 200mg; SYP-1018 200mg, Intravenous administration; Drug: Voriconazole 200mg; Voriconazole 200mg, Intravenous administration
Experimental: Sequence 2; Voriconazole 200mg → SYP-1018 200mg	Drug: SYP-1018 200mg; SYP-1018 200mg, Intravenous administration; Drug: Voriconazole 200mg; Voriconazole 200mg, Intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameters	AUClast, Cmax	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameters	AUCinf, Tmax, T1/2, CL	pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h
Safety	Adverse events, Laboratory assessments, Vital signs, Electrocardiograms(ECGs)	16 days

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 29, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 24, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Voriconazole
• Other Study ID Numbers: SYP1018