Ignite Creation Date:
2024-05-06 @ 12:23 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03744637
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2018-11-13
Brief Title:
A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance MK-5475-002
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Study to Assess the Effect of Single Doses of MK -5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2023-01
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 of MK-5475 in participants with Group 1 pulmonary arterial hypertension PAH will assess the safety tolerability and pharmacokinetics PK of inhaled MK-5475 There is no formal hypothesis to be tested
Detailed Description:
In Part 1 one panel Panel A of up to 8 participants will dose in up to 3 dosing periods with a minimum washout of 7 days between dosing periods In each dosing period 6 participants will receive MK-5475 and 2 will receive placebo with 2 different participants receiving placebo in each of the dosing periods Review of available safety data will occur prior to escalating to the next dose level
Participants from Part 1 may continue into Part 2 which will assess safety tolerability pharmacokinetics PK and pharmacodynamics PD of single-dose inhaled MK-5475 Three additional panels of participants Panels B C and D will be enrolled into Part 2 Participants in Panel A will participate in 2 open-label dosing periods to assess PD measures associated with right heart catherization RHC Period 2 and functional respiratory imaging FRI Period 3 Participants in Panels B C and D will participate in 3 dosing periods Period 1 open-label assessment of safetytolerability and PK Period 2 FRI period and Period 3 RHC period
Participants from Part 1 may continue into Part 2 which will assess safety tolerability pharmacokinetics PK and pharmacodynamics PD of single-dose inhaled MK-5475 Three additional panels of participants Panels B C and D will be enrolled into Part 2 Participants in Panel A will participate in 2 open-label dosing periods to assess PD measures associated with right heart catherization RHC Period 2 and functional respiratory imaging FRI Period 3 Participants in Panels B C and D will participate in 3 dosing periods Period 1 open-label assessment of safetytolerability and PK Period 2 FRI period and Period 3 RHC period
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-5475-002 | OTHER | Merck Study Number | None |