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

NCT06589635 | Completed Phase 1

• 1 other identifier: 2023-ADC189-I-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

ADC-189 and itraconazole

EXPERIMENTAL

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

Drug: ADC-189 and Itraconazole

Interventions

ADC-189 and Itraconazole 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.

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

ADC-189 and itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiaxing AnDiCon Biotech Co.,Ltd: lead

Study Sites (1)

The First Affilicated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Huan Zhou

  The First Affilicated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: July 16, 2024
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)