PAC-14028 in Healthy Male Volunteers

A Dose-block Randomized, Double-blind, Placebo-controlled Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of PAC-14028 After Oral Administration in Healthy Male Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01264224

Enrollment

Registered

2010-12-21

Start date

2010-12-31

Completion date

Unknown

Last updated

2014-01-22

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

Conditions

Healthy

Brief summary

1. Primary Objective: * To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers. 2. Secondary Objective: * To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral dosing of PAC-14028 in healthy male volunteers.

Interventions

DRUGPAC-14028

tablets, oral administration, single/multiple dosing, dose escalation

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy men aged 20 to 45 years at the time of screening 2. Whose weight is 50kg or more, but less than 90 kg, and whose body mass index(BMI) is 19.0 kg/m\^2 or more but less than 27 kg/m\^2 -BMI (kg/m\^2) = weight(kg) /{height(m)}\^2 3. Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.

Exclusion criteria

1. Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system, psychical disorders or blood tumor 2. Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty ) 3. Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc) 4. Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Safety/Tolerability	—	AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests

Secondary

Measure	Time frame	Description
Pharmacokinetics/dynamics	—	* PK:Concentration of PAC-14028 in Blood and Urine; Cmax, AUC * PD:Heat pain threshold/tolerance

Countries

South Korea

Outcome results

None listed

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