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Completed

NCT Number: NCT07229560

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants

This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-55 years;
  • Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;
  • Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;
  • Take contraception.

Exclusion criteria

  • Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;
  • Severe infection, severe trauma or major surgery;
  • Any medications in the two weeks before screening or baseline period;
  • History of blood donation or severe blood loss;
  • Have been vaccinated within 3 months before the screening or baseline period;
  • History of smoking or excessive alcohol or drug abuse;
  • History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;
  • Other situations in which the researcher judges unsuitable.

Treatment and study plan

HRS-8080 Tablet

Drug

HRS-8080 tablet, specified dose on specified days.

Itraconazole capsule

Drug

Itraconazole capsule, specified dose on specified days.

Primary outcomes

  1. Maximum concentration (Cmax) of HRS-8080.

    Time frame: From Day 1 to Day 11.

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080.

    Time frame: From Day 1 to Day 11.

  3. Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.

    Time frame: From Day 1 to Day 11.

Secondary outcomes

  1. Time to maximum plasma concentration (Tmax) of HRS-8080.

    Time frame: From Day 1 to Day 11.

  2. Terminal elimination half-life (t1/2) of HRS-8080.

    Time frame: From Day 1 to Day 11.

  3. Apparent volume of distribution (Vz/F) of HRS-8080.

    Time frame: From Day 1 to Day 11.

  4. Clearance (CL/F) of HRS-8080.

    Time frame: From Day 1 to Day 11.

  5. Adverse events (AEs).

    Time frame: From Day 1 to Day 17.

  6. Serious adverse events (SAEs).

    Time frame: From Day 1 to Day 17.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Jan 14, 2026

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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