Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01656408
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2012-07-12
Brief Title:
A Multiple Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of MK-8150 MK-8150-002
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multiple Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of MK-8150
Status:
COMPLETED
Status Verified Date:
2018-08
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 randomized double-blind placebo-controlled multiple-rising-dose study will evaluate the safety tolerability pharmacokinetics and pharmacodynamics of MK-8150 in healthy young men in male participants with mild to moderate hypertension in elderly male and female participants with mild to moderate hypertension and in male and female participants with resistant hypertension A primary study hypothesis is that there is at least one dose that does not increase heart rate HR to a clinically meaningful extent in male participants with mild to moderate hypertension and in elderly participants with mild to moderate hypertension on either Day 1 or the last Day of multiple dosing Daylast as measured by Time-weighted Average Across 24 hours TWA0-24hrs The hypothesis is met if mean increase MK-8150 - placebo in TWA0-24hrs HR in the identified groups is 15 beats per minute on Day 1 and Daylast
Detailed Description:
Ten panels Panels A-J consisting of 103 participants in total will be randomized to receive either MK-8150 or matching placebo
Males 18 to 55 years of age inclusive with mild to moderate hypertension will be randomized in Panels A-D and will receive either MK-8150 or placebo as once daily treatment for 10 consecutive days
Elderly males and females 65 to 80 years of age inclusive with mild to moderate hypertension will be included in Panels E and F and will receive a single dose of either MK-8150 or placebo on Study Day 1 followed by at least 5 days of wash-out before proceeding to once daily treatment of the same randomized treatment at a lower dose for 10 consecutive days
Participants 18 to 65 years of age with resistant hypertension will be enrolled in Panels H and will receive in randomized sequences of MK-8150placebo or placeboMK-8150 in 2 treatment periods There will be a minimum 3 weeks washout period between the 2 treatment periods in Panel H
Healthy males 18 to 55 years of age inclusive will be enrolled in Panel G and will receive MK-8150 or matching placebo once daily for 28 days Participants randomized to MK-8150 in Panel G who meet all of the dose-escalation criteria and have not met any of the hemodynamic stopping criteria will be eligible for dose increases on Day 8 Day 15 and Day 22 If dose escalation criteria are not met or if the Investigator or Sponsor elects not to increase the dose then the participant will continue on the current dose and will be eligible for a dose increase at the next dose-escalation decision day if all dose-escalation criteria are met at that time
Male participants 18 to 65 years of age inclusive with mild to moderate hypertension will be randomized in Panels I and J In each panel 18 participants will receive either MK-8150 or matching placebo as once daily treatment for up to 28 consecutive days Participants who are randomized to placebo will receive placebo throughout the study On Days 8 15 and 22 in both Panels I and J participants will be eligible for dose-escalation down-dosing or continuing their current dose depending on their hemodynamic status Participants in Panels I and J who meet down-dosing criteria at any time during the study will have their doses reduced to the previous well-tolerated dose level until the next dose-escalation decision day or through the end of the study whichever is first
Males 18 to 55 years of age inclusive with mild to moderate hypertension will be randomized in Panels A-D and will receive either MK-8150 or placebo as once daily treatment for 10 consecutive days
Elderly males and females 65 to 80 years of age inclusive with mild to moderate hypertension will be included in Panels E and F and will receive a single dose of either MK-8150 or placebo on Study Day 1 followed by at least 5 days of wash-out before proceeding to once daily treatment of the same randomized treatment at a lower dose for 10 consecutive days
Participants 18 to 65 years of age with resistant hypertension will be enrolled in Panels H and will receive in randomized sequences of MK-8150placebo or placeboMK-8150 in 2 treatment periods There will be a minimum 3 weeks washout period between the 2 treatment periods in Panel H
Healthy males 18 to 55 years of age inclusive will be enrolled in Panel G and will receive MK-8150 or matching placebo once daily for 28 days Participants randomized to MK-8150 in Panel G who meet all of the dose-escalation criteria and have not met any of the hemodynamic stopping criteria will be eligible for dose increases on Day 8 Day 15 and Day 22 If dose escalation criteria are not met or if the Investigator or Sponsor elects not to increase the dose then the participant will continue on the current dose and will be eligible for a dose increase at the next dose-escalation decision day if all dose-escalation criteria are met at that time
Male participants 18 to 65 years of age inclusive with mild to moderate hypertension will be randomized in Panels I and J In each panel 18 participants will receive either MK-8150 or matching placebo as once daily treatment for up to 28 consecutive days Participants who are randomized to placebo will receive placebo throughout the study On Days 8 15 and 22 in both Panels I and J participants will be eligible for dose-escalation down-dosing or continuing their current dose depending on their hemodynamic status Participants in Panels I and J who meet down-dosing criteria at any time during the study will have their doses reduced to the previous well-tolerated dose level until the next dose-escalation decision day or through the end of the study whichever is first
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 |
|---|---|---|---|
| 2012-002596-34 | EUDRACT_NUMBER | None | None |