Healthy Adults
Conditions
Brief summary
This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults. Participants in this study will complete screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.
Interventions
DRUGADC-189 and Itraconazole
Part 1: Day 1, fasting condition, 45 mg ADC189, administered orally Part 2: Day 22, 200 mg itraconazole bid, taken orally after meals. Day 23-Day 25, 200 mg itraconazole was taken orally after meals. Day 26, 45 mg ADC-189 and 200 mg itraconazole was taken orally after meals. Day 27-Day 39, 200 mg itraconazole was taken orally after meals.
Sponsors
Jiaxing AnDiCon Biotech Co.,Ltd
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Sign informed consent, be capable of and willing to comply with study restrictions and procedures. * Healthy adult subjects aged 18 to 55 years. * Weight \>=50kg for males, and \>=45kg for females, BMI 19-26 kg/m\^2. * No clinical significance in physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal ultrasound, and chest X-ray examination.
Exclusion criteria
* Subjects who participated in other drug trials within 3 months before screening * Hospital admission or major surgery within 4 weeks prior to screening or a preplanned hospital admission during study participation * Donated or lost ≥400 mL of blood in the previous 3 months before screening * Have a history of allergic diseases (asthma, urticaria, eczema, etc.), or food allergies * A history of drug abuse in the past five years * Any condition or finding that in the Investigator's opinion would put the participant or study conduct at risk if the participant were to participate in the study * Unable to complete this study for other reasons or the Investigator believes that he or she should be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC[0-∞] of ADC-189 | Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40 | Pharmacokinetics (PK) parameter: Area under the curve from time 0 hour to ∞ |
| Cmax of ADC-189 | Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40 | PK parameter: Maximum observed concentration |
| AUC[0-t] of ADC-189 | Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40 | PK parameter: Area under the curve from time 0 to 336 hour |
| Adverse events (AEs) | Day 1 to Day 43 | Number of subjects reporting AEs |
Countries
China
Outcome results
None listed