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Completed

NCT Number: NCT06372223

A Food Effect Study of SPH5030 Tablets.

The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Second Hospital ,Sichuan University

Chengdu, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fully informed subjects who voluntarily sign the ICF；
  • Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.

Exclusion criteria

  • Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;
  • Subjects with abnormal test results during the screening period；
  • Subjects who have difficulty in venous blood collection;
  • Subjects who cannot accept uniform diet or have difficulty swallowing;
  • Other situations that meet the exclusion criteria.

Treatment and study plan

SPH5030

Drug

SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: Approximately 2 months

    PK（Pharmacokinetics）

  2. Peak time（Tmax）

    Time frame: Approximately 2 months

    PK（Pharmacokinetics）

  3. Area under the plasma concentration versus time curve (AUC)

    Time frame: Approximately 2 months

    PK（Pharmacokinetics）

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Approximately 2 months

    Adverse event type, incidence, duration

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

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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