CompletedPhase 1

SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects

China70 participantsStarted 2023-05-29

Plain-language summary

To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia. To evaluate the safety and tolerability of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacodynamics (PD) profile of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacokinetics profile of SAP-001 tablets in healthy Chinese subjects under fasted/fed conditions.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Acute decompensated heart failure, including exacerbation of chronic heart failure, manifests as signs and symptoms requiring hospitalization and/or intravenous diuretic therapy \[New York Heart Association (NYHA) class III to IV\], or hemodynamically significant valvular disease and/or other vascular obstructive lesions within 3 months prior to the screening visit;
. Any of the following within 6 months prior to the screening visit:
. History of clinically significant cardiac arrhythmia, including but not limited to any of the following:
. Acute decompensated heart failure, including exacerbation of chronic heart failure, manifests as signs and symptoms requiring hospitalization and/or intravenous diuretic therapy \[New York Heart Association (NYHA) class III to IV\], or hemodynamically significant valvular disease and/or other vascular obstructive lesions within 3 months prior to the screening visit;
. Any of the following within 6 months prior to the screening visit:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

maximum concentration (Cmax)

Timeframe: 168 hours

area under the drug concentration-time curve from time 0 to the last measurable concentration sample collection time t (AUC0-t)

Timeframe: 168 hours

area under the drug concentration-time curve from time 0 to 168 hours (AUC0-168h)

Timeframe: 168 hours

time to maximum concentration (Tmax)

Timeframe: 168 hours

elimination half-life (t1/2)

Timeframe: 168 hours

cumulative urinary excretion from 0 to 168 h (Ae0-168h)

Timeframe: 168 hours

cumulative urinary excretion rate, renal clearance (CLR168h)

Timeframe: 168 hours

Trial details

NCT IDNCT06678581

SponsorShanton Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-20

View on ClinicalTrials.gov More Gout trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Acute decompensated heart failure, including exacerbation of chronic heart failure, manifests as signs and symptoms requiring hospitalization and/or intravenous diuretic therapy \[New York Heart Association (NYHA) class III to IV\], or hemodynamically significant valvular disease and/or other vascular obstructive lesions within 3 months prior to the screening visit;
. Any of the following within 6 months prior to the screening visit:
. History of clinically significant cardiac arrhythmia, including but not limited to any of the following:
. Acute decompensated heart failure, including exacerbation of chronic heart failure, manifests as signs and symptoms requiring hospitalization and/or intravenous diuretic therapy \[New York Heart Association (NYHA) class III to IV\], or hemodynamically significant valvular disease and/or other vascular obstructive lesions within 3 months prior to the screening visit;
. Any of the following within 6 months prior to the screening visit:

What they're measuring

maximum concentration (Cmax)

Timeframe: 168 hours

area under the drug concentration-time curve from time 0 to the last measurable concentration sample collection time t (AUC0-t)

Timeframe: 168 hours

area under the drug concentration-time curve from time 0 to 168 hours (AUC0-168h)

Timeframe: 168 hours

time to maximum concentration (Tmax)

Timeframe: 168 hours

elimination half-life (t1/2)

Timeframe: 168 hours

cumulative urinary excretion from 0 to 168 h (Ae0-168h)

Timeframe: 168 hours

cumulative urinary excretion rate, renal clearance (CLR168h)

Timeframe: 168 hours