A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762397

Enrollment

Registered

2013-01-07

Start date

2012-12-31

Completion date

Unknown

Last updated

2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Ulcer, Gastritis

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.

Interventions

DRUGPMK-S005

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Safety	8day	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
Pharmacokinetics	8day	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026