A Food Effect Study of SPH5030 Tablets. | NCT06372223

Studies
A Food Effect Study of SPH5030 Tablets.

NCT06372223

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Status

Completed

Last Update Posted

Apr 17, 2024Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Advanced Solid Tumor

Interventions

SPH5030
SPH5030

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2024Actual

Primary Completion Date

Mar 25, 2024Actual

Completion Date

Mar 25, 2024Actual

First Submitted Date

Apr 15, 2024

First Submission Date that Met QC Criteria

Apr 15, 2024

First Posted Date

Apr 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental		Drug: SPH5030
Group B	Experimental		Drug: SPH5030

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPH5030	Drug	SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Adverse event type, incidence, duration	Approximately 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Second Hospital ,Sichuan University		Chengdu			China