Clinical trial NCT05617651: Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T
Official title: Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T in Healthy Adult Volunteers Under Fed Condition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: proton pump inhibitor
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults

Detailed description: Phase 1 study to evaluate the safety and the pharmacokinetics of IY-NT-T in healthy adult volunteers under fed condition

Eligibility criteria: Inclusion Criteria:

1. Volunteers aged 19 years and above at screening
2. A volunteer who weighs ≥ 50kg (≥ 45kg for women) and has a body mass index(BMI)\* of ≥18.0 and ≤ 30 at screening

   \*BMI(body mass index, kg/m\^2)= Body weight (kg)/\[height (m)\^2\]
3. A volunteer who has no congenital or chronic diseases, no pathological symptoms, or findings from medical examination at screening
4. A volunteer who is determined by the principal investigator or sub-investigator(responsible physician) as eligible as a subject based on diagnostic tests( hematology, hematochemical, serum, urinalysis) and electrocardiogram tests established and conducted according to the characteristics of the study drug
5. A volunteer and their spouse or partner, who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of study drug

   \* Contraception methods: Intrauterine device, vasectomy, tubal ligation and contraceptive barrier methods (male condoms, women condoms, cervical caps. Contraceptive diaphragm, sponge,etc) used in combination or if spermicide is used, two or more contraceptive barrier methods
6. A volunteer who voluntarily provided written consent to participation in the entire study process after being fully informed of the study objective, contents, characteristics of the study drugs, and expected adverse reactions, prior to study participation

Exclusion Criteria:

1. A volunteer who has a history or present symptoms of clinically significant disorders relating to any of the following: digestive system, cardiovascular system, endocrine system, respiratory system, blood and lymphatic, infectious disease, renal, urinary, and reproductive, system, nervous system, musculoskeletal system, immune system, otolaryngology, skin and subcutaneous tissue system, and ophthalmic system
2. A volunteer who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
3. A volunteer who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first dose or who has taken drugs that may interfere with clinical study within 10 days prior to the first dose(Provided that, participation may be considered based on drug-drug interaction, pharmacokinetics and pharmacodynamics(such as half-life) of study drug)
4. A volunteer who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the study drug
5. A volunteer who has participated in whole blood donation within 8 weeks prior to first dose, or apheresis donation within w weeks prior to first dose, or received blood donation within 4 weeks prior to first dose.
6. A volunteer that meets any of the following conditions within 1 month prior to first dose

   * Average alcohol intake(for men): \> 21 glass/week
   * Average alcohol intake(for women): \> 14 glass/week (1 glass = 50ml of soju or 30ml of liquor, or 250ml of beer)
   * Average cigarette smoking: \> 20 cigarettes per day.
7. A volunteer that meets any of the following categories

   * Volunteer who is hypersensitive to the active ingredient or other ingredients of this drug
8. Patients that meet any of the following conditions

   * Gastric ulcer patients possibly related to a malignant tumor
   * Hepatic disorder or renal disorder patients
   * Patients receiving Atazanavir
   * Patients receiving Rilpivirine-containing products
9. A volunteer who is considered by the investigator to be ineligible to participate in this study for other reasons
10. Pregnant or nursing women

Primary outcomes:
measure: Ilaprazole AUCt
timeFrame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
measure: Ilaprazole Cmax
timeFrame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Secondary outcomes:
measure: Ilaprazole AUC∞
timeFrame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
measure: Ilaprazole tmax
timeFrame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
measure: Ilaprazole t1/2
timeFrame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
measure: Ilaprazole tmax-tlag
timeFrame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
measure: Ilaprazole intra-subject tlag difference
timeFrame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H plus Yangji Hospital
state: Gwanak-gu
Study officials:
affiliation: H Plus Yangji Hospital
name: Jae Woo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: