The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
NCT Number: NCT07715175
This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 1
Hefei, Anhui, 230022, China
Subjects of this study will be admitted to the Phase I ward of the research center one day before drug administration . On the first day, subjects will orally take a single dose of D-2570. The researchers will collect a series of blood and urine samples before and after drug D - 2570 administration to determine the drug concentration and evaluate the pharmacokinetic characteristics. The subjects can leave site after completing the safety evaluation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
receive a single dose of D-2570
Time frame: Through study completion (approximately Day9)
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Time frame: Through study completion (approximately Day9)
Maximum observed plasma concentration-Cmax
Time frame: Through study completion (approximately Day9)
The main PK parameters Half-life -t1/2
Time frame: Through study completion (approximately Day9)
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Time frame: Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)
Time frame: Through study completion (approximately Day9)
The main PK parameters-Vz/F (apparent volume of distribution)
Time frame: Through study completion (approximately Day9)
The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine
Time frame: Through study completion (approximately Day9)
The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine
Time frame: Through study completion (approximately Day9)
The renal clearance rate (CLR)of D - 2570 and its metabolites in urine
Time frame: Through study completion (approximately Day9)
Incidence of adverse events
Contact information is provided by the study sponsor or research team.
Dingli Yao, Bachelor's
CONTACT
Huan Zhou, Doctor
CONTACT
InventisBio Co., Ltd
Industry
A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function
Acronym: D2570-107
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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