Phase 1
Completed N=31
Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)
Source: ClinicalTrials.gov NCT01244035 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Adverse Events (AEs) — 9; 16; 8; 9 Participants
Summary
This was designed as a two part study comprising sequential double-dummy, placebo controlled 3-period randomized crossover studies. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266. Only Part I of the study was completed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events (AEs) |
9; 16; 8; 9 | — |
| PRIMARY Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3 |
83.4; 23.7; 120; 69.3 | — |
| PRIMARY Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4 |
135; 139 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3 |
17.4; 8.63; 20.5; 11.0 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of MK-8266 on Day 4 |
23.1; 23.3 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3 |
4.0; 16.0; 4.0; 16.0 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 4 |
4.0; 4.0 | — |
| PRIMARY Change From Baseline in Heart Rate (HR) |
2.78; 5.84; 1.68 | 0.1325 |
| PRIMARY Change From Baseline in Diastolic Blood Pressure (DBP) |
-3.21; -3.04; -0.28 | 0.0212 sig |
Eligibility Criteria
Inclusion Criteria
- Participant has essential hypertension who is in grade 1 or 2 hypertension according to the European Society of Hypertension (ESH) as delineated in the European Society of Cardiology (ESC) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.
- Otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator
- Participant is generally in good health with the exception of hypertension
- Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months
Exclusion Criteria
- Participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study
- Participant has a history of stroke, chronic seizures, or major neurological disorder
- Participant has a disability that can interfere with rising from a semi-recumbent position to the standing position
- Participant has a personal or family history of a bleeding or clotting disorder
- Participant has a history of frequent nosebleeds or recurrent or active gingivitis
- Participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study
- Participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage
- Participant is categorized as class II or greater according to the New York Heart Association (NYHA) functional classification for heart failure
- Participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as St. John's Wort) during the study
- Participant anticipates using phosphodiesterase (PDE5) inhibitors [sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®)] during the study
- Participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day)
- Participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study
- Participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food
Data sourced from ClinicalTrials.gov (NCT01244035). 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. Informational only — not medical advice.