NCT06372223

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

21 days

First QC Date

April 15, 2024

Last Update Submit

April 15, 2024

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

  • Peak Plasma Concentration (Cmax)

    PK（Pharmacokinetics）

    Approximately 2 months

  • Peak time（Tmax）

    PK（Pharmacokinetics）

    Approximately 2 months

  • Area under the plasma concentration versus time curve (AUC)

    PK（Pharmacokinetics）

    Approximately 2 months

Secondary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Approximately 2 months

Study Arms (2)

Group A

EXPERIMENTAL
Drug: SPH5030

Group B

EXPERIMENTAL
Drug: SPH5030

Interventions

SPH5030DRUG

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

Group A

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Second Hospital ,Sichuan University

Chengdu, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 17, 2024

Study Start

March 4, 2024

Primary Completion

March 25, 2024

Study Completion

March 25, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

CN(1)