A Food Effect Study of SPH5030 Tablets.

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06372223
• Other study ID #: SPH5030-102
• Status: Completed
• Phase: Phase 1
• Start date: March 4, 2024
• Est. completion date: March 25, 2024

Study information

• Verified date: April 2024
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Fully informed subjects who voluntarily sign the ICF;

2. Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.

Exclusion Criteria:

1. Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;

2. Subjects with abnormal test results during the screening period;

3. Subjects who have difficulty in venous blood collection;

4. Subjects who cannot accept uniform diet or have difficulty swallowing;

5. Other situations that meet the exclusion criteria.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	West China Second Hospital ,Sichuan University	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	PK(Pharmacokinetics)	Approximately 2 months
Primary	Peak time(Tmax)	PK(Pharmacokinetics)	Approximately 2 months
Primary	Area under the plasma concentration versus time curve (AUC)	PK(Pharmacokinetics)	Approximately 2 months
Secondary	Incidence of Treatment-Emergent Adverse Events	Adverse event type, incidence, duration	Approximately 2 months