Phase 1
N=25
A Single Dose Study of MK-8266 (MK-8266-001)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01025791 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants Who Experienced One or More Adverse Events — 2; 3; 5; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MK-8266 0.1 mg (Drug); MK-8266 1.0 mg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced One or More Adverse Events |
2; 3; 5; 2; 3; 1 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Aortic Augmentation Index - Time-Weighted Average 0-24 Hours |
-8.79; -2.96; -1.73; -7.42; -5.70; -1.73 | 0.003 sig |
| PRIMARY MK-8266 Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) |
264; 441; 216; 350; 528; 623 | — |
| PRIMARY MK-8266 PK Parameter Observed Maximum (Peak) Plasma Concentration (Cmax) |
2.28; 4.33; 11.4; 22.2; 20.5; 7.46 | — |
| PRIMARY MK-8266 PK Parameter Observed Time to Reach Cmax (Tmax) |
2.5; 4.0; 3.5; 4.0; 3.5; 3.0 | — |
| PRIMARY MK-8266 PK Parameter Apparent t1/2 |
13.6; 11.7; 9.2; 12.0; 10.4; 12.8 | — |
| SECONDARY Effect of Food on MK-8266 PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24hr) Following Administration of Single Oral Doses of MK-8266 at 0.4 mg to Healthy Male Participants |
59.6; 52.9 | — |
| SECONDARY Effect of Food on MK-8266 PK Parameter Cmax Following Administration of Single Oral Doses of MK-8266 at 0.4 mg to Healthy Male Participants |
7.5; 7.3 | — |
| SECONDARY Time-Weighted Average of Heart Rate (0-12 Hours) |
58.79; 61.65; 56.36; 66.40; 63.71; 59.32 | 0.396 |
Summary
A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of subjects with mild to moderate hypertension. The primary hypotheses for the study are that MK-8266 given as single doses is sufficiently safe and well tolerated to permit continued clinical investigation in healthy young male volunteers and male participants with mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a single oral dose of MK-8266 that is sufficiently safe and well-tolerated, postdose mean time-weighted average across 24 hours of aortic augmentation index (TWA0-12hrs AIx) is reduced compared to placebo. A mean decrease of ≥ 5 percentage points is considered clinically meaningful.
Eligibility Criteria
Inclusion Criteria
- For Panel A and B Participant is a healthy male between 18 to 45 years of age. For Panel C Participant is a male with essential hypertension between 18 to 55 years of age
- A non-smoker
Exclusion Criteria
- Has a history of stroke, chronic seizure or major neurological disorder
- Has a disability that can interfere with rising from a sitting position to the standing position
- Has a personal of family history of bleeding or clotting disorders
- Has a history of cancer
- Is unable to refrain from or anticipates the use of any prescription or nonprescription drug during the study
- Consumes excessive amounts of caffeine or alcohol
- Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
Data sourced from ClinicalTrials.gov (NCT01025791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.