NCT01657201

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

July 29, 2012

Last Update Submit

December 20, 2012

Conditions

Systemic Mycotic Infection

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics parameters

    AUClast, Cmax

    pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h

Secondary Outcomes (2)

  • Pharmacokinetics parameters

    pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h

  • Safety

    16 days

Study Arms (2)

Sequence 1

EXPERIMENTAL

SYP-1018 200mg → Voriconazole 200mg

Drug: SYP-1018 200mgDrug: Voriconazole 200mg

Sequence 2

EXPERIMENTAL

Voriconazole 200mg → SYP-1018 200mg

Drug: SYP-1018 200mgDrug: Voriconazole 200mg

Interventions

SYP-1018 200mgDRUG

SYP-1018 200mg, Intravenous administration

Sequence 1Sequence 2
Voriconazole 200mgDRUG

Voriconazole 200mg, Intravenous administration

Sequence 1Sequence 2

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2012

First Posted

August 6, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations

KR(1)