Status:
COMPLETED
A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
This study will evaluate safety, tolerability and effects on central diastolic blood pressure (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and in male part...
Detailed Description
Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and B, 8 participants will alt...
Eligibility Criteria
Inclusion
- Systolic blood pressure (SBP) \> 110 and ≤ 140 mmHg for Panels A and B, SBP values of 140-175 mmHg and diastolic blood pressure (DBP) of 90-105 mmHg on at least three different occasions at the prestudy (screening) visit for Panel C. Participants being treated with medication for their hypertension may be included as long as they are titrated off of their medication
- Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2
- Healthy (with the exception of hypertensive subjects in Panel C)
- No clinically significant abnormality on electrocardiogram (ECG)
- No history of clinically significant cardiac disease
- No history of heart failure
- Nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months
Exclusion
- Mentally or legally incapacitated
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal, cardiovascular (except mild to moderate hypertension), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Functional disability that can interfere with rising from a sitting position to the standing position
- History of cancer (malignancy)
- History of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
- Positive for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
- Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks
- Has participated in another investigational trial within 4 weeks
- Unable to refrain from or anticipates the use of any medication during the study
- Anticipates using medication for erectile dysfunction during the study
- Uses or anticipates using organic nitrates during the study (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, pentaerythritol)
- Anticipates using cytochrome P450 inhibitors (e.g. ketoconazole) or inducers (e.g. rifampin) during the study
- Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages per day
- Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
- Regular user (including recreational user) of illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year
Key Trial Info
Start Date :
March 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01798849
Start Date
March 15 2013
End Date
July 17 2013
Last Update
July 22 2019
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