Status:
COMPLETED
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502
Lead Sponsor:
Korea University Anam Hospital
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.
Eligibility Criteria
Inclusion
- Healthy volunteers aged between ≥20 and ≤45 years old
- Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
- Subject who voluntarily agrees to participate in this study and signs the informed consent form.
Exclusion
- History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
- With symptoms indicating acute illness within 28 days prior to the first IP administration.
- Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
- Any clinically significant activity of chronic medical illness.
- History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included).
- Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL.
- Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration or use of over-the-counter medications (OTC) and vitamin products within 10 days prior to study drug administration.
- Inability to take standard hospital diet.
- Donation of blood within 60 days prior to study drug administration or apheresis within 20 days, or blood transfusion within 30 days prior to the first IP administration.
- Exposure to any investigational drug or placebo within 90 days prior to the last IP administration.
- Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week).
- Any use of tobacco or nicotine within three months.
- Subjects rejected to use clinically effective contraceptive methods during the study period.
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Key Trial Info
Start Date :
January 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04018378
Start Date
January 6 2017
End Date
September 17 2018
Last Update
July 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Seoul, South Korea, 136-705