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 range18 Years – 65 Years

SexALL

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:
✕. History of clinically significant cardiac arrhythmia, including but not limited to any of the following:

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 range18 Years – 65 Years

SexALL

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:
✕. History of clinically significant cardiac arrhythmia, including but not limited to any of the following:

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