A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral… (NCT06155487) | Clinical Trial Compass
By InvitationPhase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects
South Korea68 participantsStarted 2023-12-05
Plain-language summary
Preliminary evaluate of pharmacokinetics, pharmacodynamics, safety and tolerability after oral administration of AJH-2947 in healthy Korean or Caucasian male subjects
Who can participate
Age range19 Years – 55 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy Korean or Caucasian adult males aged 19 to 55 years old, based on the date of written consent
✓. Individuals with a body weight between 50.0 kg and 90.0 kg and a body mass index (BMI) ranging from 18.5 kg/m2 to less than 30.0 kg/m2
✓. Individuals who agree to stay in the CTC ward until discharge and consent to the use of sunscreen until the end of the clinical trial (PSV)
✓. Individuals who have heard a detailed explanation of the trial, fully understand it, voluntarily decide to participate, and provide written consent before the screening examination
✓. Individuals deemed suitable by the investigator based on medical history, vital signs, 12-lead electrocardiogram (ECG), physical examination, and clinical laboratory tests performed during the screening.
Exclusion criteria
✕. Individuals with clinically significant diseases or a history of diseases related to the liver, kidney, nervous system, immune system, respiratory system, digestive system, endocrine system, blood/tumors, cardiovascular system, urinary system, mental disorders, etc.
✕. In the multiple-dose trial, individuals with skin lesions, tattoos on both forearms or show hypersensitivity or allergic reactions to capsaicin cream who may affect the pharmacodynamic evaluation of the investigational product.
✕. Individuals with gastrointestinal diseases (such as gastrointestinal ulcers, gastritis, gastric spasm, gastroesophageal reflux disease, and Crohn's disease) or a history of surgery that may affect the safety and pharmacokinetic evaluation of the investigational product (excluding simple appendectomy and hernia repair)
What they're measuring
1
Part A (SAD): Plasma concentrations of AJH-2947
Timeframe: Day 1 to Day 5
2
Part A (SAD): Urine concentrations of AJH-2947
Timeframe: Day 1 to Day 4
3
Part A (SAD): Maximum observed concentration [Cmax]
Timeframe: Day 1 to Day 5
4
Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration [AUClast]
Timeframe: Day 1 to Day 5
5
Part A (SAD): Time to reach peak or maximum observed concentration [Tmax]
Timeframe: Day 1 to Day 5
6
Part B (MAD): Plasma concentrations of AJH-2947
Timeframe: Day 1 to Day 18
7
Part B (MAD): Maximum observed concentration [Cmax]
Timeframe: Day 1 to Day 18
8
Part B (MAD): The partial area from dosing time to dosing time plus dosing interval [AUCÏ„]
✕. Individuals with a medical history of hypersensitivity reactions to the main active ingredient or components of the investigational product or to drugs in the same class as the main active ingredient
✕. Individuals with positive results for hepatitis B (HBV) test, hepatitis C (HCV) test, syphilis (RPR) test, or HIV test conducted during screening
✕. Individuals who exhibited systolic blood pressure \< 80 mmHg or ≥ 140 mmHg or diastolic blood pressure \< 45 mmHg or ≥ 90 mmHg during vital sign measurements in the supine position after a rest period of at least three minutes
✕. Individuals with a history of drug abuse or who tested positive for drug abuse in the urine drug screening test
✕. Individuals who have taken prescription drugs or traditional herbal medicine within 2 weeks before the scheduled first dose of the investigational product or have taken any over-the-counter medicines, health-functional foods, or vitamin supplements within 1 week, or are expected to take them
9
Part B (MAD): Time of maximum observed concentration [Tmax]
Timeframe: Day 1 to Day 18
10
Part B (MAD): Maximum observed concentration occurring at time Tmax,ss [Cmax,ss]
Timeframe: Day 1 to Day 18
11
Part B (MAD): At steady state, the partial area from dosing time to dosing time plus dosing interval [AUCÏ„,ss]
Timeframe: Day 1 to Day 18
12
Part B (MAD): Heat pain Threshold (The temperature at which the subject first perceives pain, ℃)
Timeframe: Predose, Day 1, Day 7, and Day 8
13
Part B (MAD): Heat pain tolerance (The Maximum temperature that the subject can tolerate, ℃)