A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Drug: ADC-189 and Itraconazole

• Registration Number: NCT06589635
• Lead Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-07-16
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Primary Completion: 2024-09-11
• Study Completion: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADC-189 and itraconazole	ADC-189 and Itraconazole	Part 1: Single dose of ADC-189 Part 2: Itraconazole with single dose of ADC-189

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affilicated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, Anhui, China