NCT01762397

Brief Summary

The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

December 20, 2012

Last Update Submit

May 29, 2014

Conditions

GastritisGastric Ulcer

Outcome Measures

Primary Outcomes (2)

  • Safety

    1. Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product. 2. Before and after physical examination 3. Before and after bital Sign: blood pressure, pulse rate, temperature. 4. Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec. 5. Lab: hematologic examination, blood coagulation examination,urine examination

    8day

  • Pharmacokinetics

    1. Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2. 2. Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery

    8day

Study Arms (1)

PMK-S005

EXPERIMENTAL
Drug: PMK-S005

Interventions

PMK-S005DRUG
PMK-S005

Eligibility Criteria

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

You may qualify if:

  • Male 20 year ≤ age ≤ 40 year.
  • Weight ≥ 55kg, IBW ±20%.
  • Patients with normal hematology, biochemistry, urinary result.
  • Patients who have not congenital or chronic disease.
  • Provision of written informed consent voluntarily.

You may not qualify if:

  • Patients having known hypersensitivity to any component of the study drug.
  • Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
  • Patients with any gastrointestinal disorders.
  • Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.
  • Drug abuser, alcoholic.
  • Patients taking ETC medication within 14 days, OTC within 7 days.
  • Patients taking other investigational product within 60 days prior to the participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam national university hospital

Daejeon, Chungcheongnam-do, 301-721, South Korea

Location

MeSH Terms

Conditions

GastritisStomach Ulcer

Interventions

PMK-S005

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesPeptic UlcerDuodenal DiseasesIntestinal Diseases

Study Design

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

Study Record Dates

First Submitted

December 20, 2012

First Posted

January 7, 2013

Study Start

December 1, 2012

Primary Completion

May 1, 2013

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

KR(1)