At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Rising Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8150
In Brief
A Phase 1 clinical trial evaluating MK-8150 2.0 mg, MK-8150 10 mg, and 17 other interventions for Hypertension and Isolated Systolic Hypertension (ISH). Completed, enrolled 34 participants.
Detailed Summary
This study will evaluate the safety and tolerability of MK-8150 and its effect on central systolic blood pressure (cSBP) and heart rate corrected augmentation index (AIx) when given as single oral doses in healthy males and in males with mild-to-moderate hypertension. A primary study hypothesis is that post dose mean change from baseline of time-weighted average across 24 hours (TWA0-24hrs) cSBP or AIx is reduced in participants administered MK-8150 compared to placebo in males with mild to moderate hypertension. A mean decrease from baseline compared to placebo of ≥5 mm Hg in TWA0-24hrs cSBP or of ≥5 percentage points in TWA0-24hrs AIx is considered clinically meaningful.
Study Details
Timeline
Interventions
Single oral 2.0-mg dose of MK-8150
Single oral 10-mg dose of MK-8150
Single oral 40-mg dose of MK-8150 without food (fasted) and with food (fed)
Single oral 90-mg dose of MK-8150
Single oral 5.0-mg dose of MK-8150
Single oral 20-mg dose of MK-8150
Single oral 60-mg dose of MK-8150
Single oral 120-mg dose of MK-8150
Single oral 160-mg dose of MK-8150
Single oral 320-mg dose of MK-8150
Single oral 600-mg dose of MK-8150
Single oral 900-mg dose of MK-8150
Single oral 1200-mg dose of MK-8150
Single oral dose-matched dose of Placebo for MK-8150
Single oral 50-mg dose of MK-8150
Single oral 100-mg dose of MK-8150
Single oral 200-mg dose of MK-8150
Single oral 400-mg dose of MK-8150
Single oral 500-mg dose of MK-8150