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Completed

NCT Number: NCT05359055

Drug-drug Interaction Study of SPH3127

A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Willing and able to provide written informed consent;
  • Chinese Male ≥18 and ≤45 years;
  • BMI≥18.5 and ≤26.0 kg/m2 and a weight ≥50.0 kg;
  • Normal or no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the vital signs, physical examination, clinical laboratory tests, and 12-lead ECG.
  • Subjects agreed to have no family planning during the study period and within 6 months after the last study drug administration, voluntarily take effective contraceptive measures and have no sperm donation plan. Non-drug contraceptive measures will be used voluntarily during the trial.
  • Subjects can communicate well with investigators, understand and comply with the requirements of this trial.

Exclusion criteria

  • Patients with diseases that need to be excluded, not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone, and other systems;
  • History of allergic diseases;
  • History of dysphagia or any gastrointestinal illness that affects drug absorption;
  • Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug;
  • People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before screening;
  • Prescribed medications, over-the-counter medications, dietary supplements, or Chinese herbal medicines were taken within 14 days prior to initial administration of the study drug;
  • Unwilling to avoid vigorous exercise from 48 hours before the first administration of the study drug to the end of the study;
  • Used of any drug that inhibits or induces hepatic metabolism of the drug in the 28 days prior to taking the study drug.
  • Those who have special dietary requirements and cannot follow a uniform diet;
  • Assessed by the investigators as unsuitable for participating in the study.

Treatment and study plan

SPH3127 tablet

Drug

100mg once daily on Day 1 and Day 8

Itraconazole

Drug

200mg once daily from Day 3 to Day10.

Rifampin

Drug

600mg once daily from Day 3 to Day13.

Primary outcomes

  1. Maximum serum concentration (Cmax) of SPH3127

    Time frame: Up to 14 days

    To characterize the PK (Pharmacokinetics) of SPH3127

  2. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127

    Time frame: Up to 14 days

    To characterize the PK (Pharmacokinetics) of SPH3127

  3. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127

    Time frame: Up to 14 days

    To characterize the PK (Pharmacokinetics) of SPH3127

Secondary outcomes

  1. Number of subjects with adverse event.

    Time frame: Up to 42 days

    Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs.

  2. Time of maximum serum concentration (Tmax) SPH3127

    Time frame: Up to 14 days

    To characterize the PK (Pharmacokinetics) of SPH3127

  3. Half-life (t1/2) of SPH3127

    Time frame: Up to 14 days

    To characterize the PK (Pharmacokinetics) of SPH3127

  4. Apparent oral clearance (CL/F) of SPH3127

    Time frame: Up to 14 days

    To characterize the PK (Pharmacokinetics) of SPH3127

  5. Apparent oral volume of distribution (Vz/F) of SPH3127

    Time frame: Up to 14 days

    To characterize the PK (Pharmacokinetics) of SPH3127

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

An Open-label, Fixed Sequence Study to Evaluate the Effects of Multi-dose of Itraconazole or Rifampin on the Pharmacokinetic Profiles of Single Dose of SPH3127 in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 3, 2022
Registry last updated
Jul 29, 2022

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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