NCT01653314

Brief Summary

The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 healthy

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

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

2 months

First QC Date

July 25, 2012

Last Update Submit

July 26, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety

    Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG

Secondary Outcomes (1)

  • Pharmacokinetics

Study Arms (2)

Megavec

EXPERIMENTAL
Drug: MegavecDrug: Glivec

Glivec

ACTIVE COMPARATOR
Drug: MegavecDrug: Glivec

Interventions

MegavecDRUG
GlivecMegavec
GlivecDRUG
GlivecMegavec

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy and male subjects aged 20 to 55 years
  • The subject has a Body weight ≥55 kg and ideal body weight (IBW) within ±20%
  • A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
  • A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.

You may not qualify if:

  • A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, hematology, neurology and psychology function or other significant diseases and history
  • Known allergy or hypersensitivity to the study medication
  • AST or ALT greater than 1.25 times the upper limit of reference range or Total bilirubin greater than 1.25 times the upper limit of reference range base on screening results
  • A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 31, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 31, 2012

Record last verified: 2012-07