Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03177603
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2017-05-23
Brief Title:
A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension PAH
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-label Dose-escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2020-03
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:
GSK2586881 a purified intravenous IV formulation of soluble recombinant human Angiotensin Converting Enzyme rhACE2 is being investigated as a treatment for PAH This GlaxoSmithKline GSK study will evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of GSK2586881 in subjects with PAH This open-label dose-escalation study will comprise of 4 separate groups based on the planned dose range and subjects in each group will be administered a single dose of GSK2586881 ranging between 01 02 04 and 08 milligram per kilogram mgkg via IV route Dose escalation will occur after 4 subjects have been dosed per cohort and review of safety tolerability PK and hemodynamic data up to 24 hours post dose has taken place A maximum of 27 subjects will be included in the study and the total duration of the study will be up to a maximum of 59 days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-000212-41 | EUDRACT_NUMBER | None | None |