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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: ADC-189 and Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affilicated Hospital of Bengbu Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ADC-189 and itraconazole; Part 1: Single dose of ADC-189 Part 2: Itraconazole with single dose of ADC-189

Drug: ADC-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.; Other Names: Part 1: Single dose of ADC-189; Part 2: Itraconazole with single dose of ADC-189

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC[0-∞] of ADC-189	Pharmacokinetics (PK) parameter: Area under the curve from time 0 hour to ∞	Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
Cmax of ADC-189	PK parameter: Maximum observed concentration	Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
AUC[0-t] of ADC-189	PK parameter: Area under the curve from time 0 to 336 hour	Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
Adverse events (AEs)	Number of subjects reporting AEs	Day 1 to Day 43

Collaborators and Investigators

• Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
• Investigators: Principal Investigator: Huan Zhou, The First Affilicated Hospital of Bengbu Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): September 11, 2024
• Study Completion (Actual): September 11, 2024

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP3A Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole; Hydroxyitraconazole
• Other Study ID Numbers: 2023-ADC189-I-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes