Clinical trial NCT06589635: A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects
Official title: A Single-center, Open-label and Sequential-dosing Clinical Trial Investigating the Drug Interaction Between ADC-189 Tablet and Itraconazole Capsule in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC[0-∞] of ADC-189
timeFrame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
measure: Cmax of ADC-189
timeFrame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
measure: AUC[0-t] of ADC-189
timeFrame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
measure: Adverse events (AEs)
timeFrame: Day 1 to Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affilicated Hospital of Bengbu Medical University
state: Anhui
Study officials:
affiliation: The First Affilicated Hospital of Bengbu Medical University
name: Huan Zhou
role: PRINCIPAL_INVESTIGATOR
References: