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

NCT ID: NCT06589635

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-16
• Study Completion Date: 2024-09-11

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADC-189 and itraconazole

Part 1: Single dose of ADC-189

Part 2: Itraconazole with single dose of ADC-189

Group Type: EXPERIMENTAL

ADC-189 and Itraconazole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiaxing AnDiCon Biotech Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huan Zhou

Role: PRINCIPAL_INVESTIGATOR

The First Affilicated Hospital of Bengbu Medical University

Locations

The First Affilicated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Countries

China

Other Identifiers

2023-ADC189-I-002

Identifier Type: -

Identifier Source: org_study_id