Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05948644
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2023-06-21
Brief Title:
The Safety Tolerability and Pharmacokinetics of TPN171H Tablets in Patients With Pulmonary Arterial Hypertension
Sponsor:
Vigonvita Life Sciences
Organization:
Vigonvita Life Sciences
Study Overview
Official Title:
Phase Ib Clinical Study on the Safety Tolerability and Pharmacokinetics of TPN171H Tablets in the Treatment of Pulmonary Arterial Hypertension PAH Patients
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exploring the safety tolerability and pharmacokinetic PK characteristics of oral TPN171H tablets in patients with Pulmonary Arterial Hypertension under continuous multiple administration conditions providing a basis for determining the administration plan and recommended dosage in phase II clinical study
Detailed Description:
This study was divided into screening period treatment period and medication follow-up period and the treatment period included 3 cycles
First cycle subjects receiving the test drug 25mg QD for 2 consecutive weeks PK blood collection on Day 1 and Day 7 and the subjects discharged and returned to the hospital on Day 14 for medication monitoring blood collection safety examination and efficacy assessment
Second cycle up to 14 weeks the second cycle is divided into monitoring and observation cycles subjects who complete the first cycle and examinations enter the second cycle with a 14 day monitoring period and 12 week observation period with the second cycle dose of 5 mg QD subjects received PK sampling on Day 7
Third cycleThe third cycle lasts for 8 days subjects receive 10mg QD for 8 days subjects received PK sampling on Day 7 subjects who completed an 8-day safety observation period on Day 8 without abnormal safety tests may be discharged After discharge into the medication follow-up period
Medication follow-up period up to 2 years subjects entering the follow-up period will continue to take the dose of the last treatment period return to hospital once every 12 weeks for safety examination and efficacy assessment until the subject intolerance or withdrawal from the study or expiration of 2 years whichever occurs first
First cycle subjects receiving the test drug 25mg QD for 2 consecutive weeks PK blood collection on Day 1 and Day 7 and the subjects discharged and returned to the hospital on Day 14 for medication monitoring blood collection safety examination and efficacy assessment
Second cycle up to 14 weeks the second cycle is divided into monitoring and observation cycles subjects who complete the first cycle and examinations enter the second cycle with a 14 day monitoring period and 12 week observation period with the second cycle dose of 5 mg QD subjects received PK sampling on Day 7
Third cycleThe third cycle lasts for 8 days subjects receive 10mg QD for 8 days subjects received PK sampling on Day 7 subjects who completed an 8-day safety observation period on Day 8 without abnormal safety tests may be discharged After discharge into the medication follow-up period
Medication follow-up period up to 2 years subjects entering the follow-up period will continue to take the dose of the last treatment period return to hospital once every 12 weeks for safety examination and efficacy assessment until the subject intolerance or withdrawal from the study or expiration of 2 years whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None