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Completed

NCT Number: NCT06589635

A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole 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.

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Key information

Conditions

Healthy Adults

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affilicated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. AUC[0-∞] of ADC-189

    Time frame: 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 ∞

  2. Cmax of ADC-189

    Time frame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40

    PK parameter: Maximum observed concentration

  3. AUC[0-t] of ADC-189

    Time frame: 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

  4. Adverse events (AEs)

    Time frame: Day 1 to Day 43

    Number of subjects reporting AEs

Sponsors and collaborators

Lead sponsor

Jiaxing AnDiCon Biotech Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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