Adults 18 to 70, any sex, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Concentration Time-curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-8892 at Day 1 and Day 28Primary· Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose on Days 1 and 28
Blood samples taken at Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose on Days 1 and 28 to determine the AUC0-24hr.
Day 1
Group
Value
95% CI
MK-8892 Panel A
0.143
0.08 – 0.24
MK-8892 Panel B
0.123
0.017 – 0.23
MK-8892 Panel C
0.192
0.09 – 0.40
Day 28
Group
Value
95% CI
MK-8892 Panel A
0.863
0.49 – 1.51
MK-8892 Panel B
0.595
0.32 – 1.11
MK-8892 Panel C
1.61
0.77 – 3.35
Number of Participants Who Experienced an Adverse Event (AE)Primary· Up to 42 days
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The number of participants that reported at least 1 AE was summarized.
Group
Value
95% CI
MK-8892 Panel A
1
MK-8892 Panel B
1
MK-8892 Panel C
4
Placebo (Panels A and B)
0
Number of Participants Who Had Study Drug Discontinued Due to an Adverse EventPrimary· Up to 28 days
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The number of participants who had study drug discontinued due to an AE was summarized.
Group
Value
95% CI
MK-8892 Panel A
0
MK-8892 Panel B
0
MK-8892 Panel C
0
Placebo (Panels A and B)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 42 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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 0.6 μM•hr.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT02078557 — A Multiple Dose Titration Study of MK-8892 in Participants With Pulmonary Hypertension and Left Heart Disease (MK-8892-0
· Phase 1
· terminated
NCT01934647 — Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003)
· Phase 1
· terminated
NCT01798849 — A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-0
· Phase 1
· completed
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 3 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01926509.