Clinical trial NCT04018378: A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: an open-label, randomized, single-dose crossover clinical trial
Primary purpose: TREATMENT

Brief summary: The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers aged between ≥20 and ≤45 years old
2. Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
3. Subject who voluntarily agrees to participate in this study and signs the informed consent form.

Exclusion Criteria:

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
2. With symptoms indicating acute illness within 28 days prior to the first IP administration.
3. Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
4. Any clinically significant activity of chronic medical illness.
5. 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).
6. Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL.
7. 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.
8. Inability to take standard hospital diet.
9. 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.
10. Exposure to any investigational drug or placebo within 90 days prior to the last IP administration.
11. Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week).
12. Any use of tobacco or nicotine within three months.
13. Subjects rejected to use clinically effective contraceptive methods during the study period.
14. Subjects having been deemed inappropriate for the trial as determined by the investigator.

Primary outcomes:
measure: AUC
timeFrame: 0 (predose) ~ 96 hours
measure: Cmax
timeFrame: 0 (predose) ~ 96 hours
Secondary outcomes:
measure: Tmax
timeFrame: 0 (predose) ~ 96 hours
measure: T1/2
timeFrame: 0 (predose) ~ 96 hours
measure: CL/F
timeFrame: 0 (predose) ~ 96 hours
measure: Vd/F
timeFrame: 0 (predose) ~ 96 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Study officials:
References: