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

AnDiCon Biotech

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: ADC-189 and Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06589635

2023-ADC189-I-002

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 1 patient group

ADC-189 and itraconazole

Experimental group

Description:

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

Treatment:

Drug: ADC-189 and Itraconazole