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Completed

NCT Number: NCT05928988

A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects

This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female subjects, aged 18 to 45 years (inclusive).
  • Female subjects body weight≥45 kg, male subjects body weight≥50 kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (inclusive).
  • Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.

Exclusion criteria

  • Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
  • Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study as determined by the investigator.
  • Subjects with positive tests for infectious diseases.
  • Subjects who have undergone major surgery within 3 months prior to screening or have undergone surgery that could significantly affect the in vivo course or safety evaluation of the study drug.
  • History of using any medication within 2 weeks prior to the first dosing.
  • Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial.
  • Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening.
  • Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse.
  • Female who are pregnant or breastfeeding, or have a positive pregnancy test.
  • Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.

Treatment and study plan

SHR8554;Itraconazole

Drug

Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm

Primary outcomes

  1. Cmax:observed maximum plasma concentration

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  2. AUC0-t :area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  3. AUC0-∞:area under the plasma concentration-time curve from time 0 to infinity

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  4. Tmax:observed time to reach Cmax

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  5. Vz :apparent volume of distribution

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  6. MRT0-∞:mean residence time from time 0 to infinity

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

Secondary outcomes

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline up to Day 18

  2. Incidence of participants with clinical laboratory abnormalities

    Time frame: Baseline up to Day 18

  3. Incidence of participants with vital signs abnormalities

    Time frame: Baseline up to Day 18

  4. Incidence of participants with physical exam abnormalities

    Time frame: Baseline up to Day 18

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

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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