NCT01548391

Brief Summary

This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

First QC Date

March 5, 2012

Last Update Submit

March 7, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety (normal results for safety tests)

    Physical examination, Vital signs

    14days

Study Arms (9)

HX-1171 20 mg (20mg 1T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 40 mg (20mg 2T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 80 mg (20mg 4T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 160 mg (20mg 8T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 300 mg (200mg 1T, 20mg 5T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 600 mg (200mg 3T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 1200 mg (500mg 2T, 200mg 1T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 1500 mg (500mg 3T)

EXPERIMENTAL
Drug: HX-1171

HX-1171 2000 mg (500mg 4T)

EXPERIMENTAL
Drug: HX-1171

Interventions

HX-1171DRUG

20mg, 200mg, 500mg

HX-1171 1200 mg (500mg 2T, 200mg 1T)HX-1171 1500 mg (500mg 3T)HX-1171 160 mg (20mg 8T)HX-1171 20 mg (20mg 1T)HX-1171 2000 mg (500mg 4T)HX-1171 300 mg (200mg 1T, 20mg 5T)HX-1171 40 mg (20mg 2T)HX-1171 600 mg (200mg 3T)HX-1171 80 mg (20mg 4T)

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males aged 20 to 40 years at screening.
  • Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

You may not qualify if:

  • History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders.
  • History of known hypersensitivity to drugs including HX-1171.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

MeSH Terms

Interventions

1-O-hexyl-2,3,5-trimethylhydroquinone

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

March 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

KR(1)