Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01926509
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2013-08-19
Brief Title:
Study to Assess the Safety Tolerability and Pharmacokinetics PK of MK-8892 in Participants With Pulmonary Arterial Hypertension PAH MK-8892-005
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A 28-Day Multiple-Dose Titration Study to Assess the Effects of MK-8892 on Safety Tolerability and Pharmacokinetics in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2018-05
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:
This study will evaluate the safety tolerability and PK of MK-8892 in participants with pulmonary arterial hypertension The primary hypothesis is that the geometric mean of MK-8892 area under the concentration time-curve from Hour 0 to 24 hours AUC0-24hr in participants with PAH will be equal to or greater than the efficacious exposure in humans of 06 μMhr
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| MK-8892-005 | OTHER | Merck | None |
| 2013-002529-51 | EUDRACT_NUMBER | None | None |