Trial Outcomes & Findings for Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003) (NCT NCT01934647)
NCT ID: NCT01934647
Last Updated: 2018-10-22
Results Overview
PVR assessments were performed throughout the right heart catheterization (RHC). Peak PVR reduction was determined to occur if 2 consecutive PVR measurements were at least 20% greater than the nadir PVR measurement.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
Baseline and up to 5 hours post-dose
Results posted on
2018-10-22
Participant Flow
Participant milestones
| Measure |
1 mg MK-8892
Participants received a single oral dose of 1 mg MK-8892.
|
4 mg MK-8892
Participants received a single oral dose of 4 mg MK-8892.
|
8 mg MK-8892
Participants received a single oral dose of 8 mg MK-8892.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003)
Baseline characteristics by cohort
| Measure |
1 mg MK-8892
n=2 Participants
Participants received a single oral dose of 1 mg MK-8892.
|
4 mg MK-8892
n=2 Participants
Participants received a single oral dose of 4 mg MK-8892.
|
8 mg MK-8892
n=3 Participants
Participants received a single oral dose of 8 mg MK-8892.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.5 Years
STANDARD_DEVIATION 17.7 • n=5 Participants
|
52.0 Years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
61.3 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
51 Years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 5 hours post-dosePopulation: Planned efficacy analysis could not be performed due to early study termination.
PVR assessments were performed throughout the right heart catheterization (RHC). Peak PVR reduction was determined to occur if 2 consecutive PVR measurements were at least 20% greater than the nadir PVR measurement.
Outcome measures
Outcome data not reported
Adverse Events
Panel A: 1 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Panel B: 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Panel C: 8 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panel A: 1 mg
n=2 participants at risk
Participants received a single oral dose of 1 mg MK-8892.
|
Panel B: 4 mg
n=2 participants at risk
Participants received a single oral dose of 4 mg MK-8892.
|
Panel C: 8 mg
n=3 participants at risk
Participants received a single oral dose of 8 mg MK-8892.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
50.0%
1/2 • Number of events 1 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
50.0%
1/2 • Number of events 1 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
50.0%
1/2 • Number of events 1 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/2 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER