A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)
NCT ID: NCT01096160
Last Updated: 2019-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2010-03-01
2010-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Panel A: MK-8266 BID, 1 mg/Placebo
MK-8266 1 mg (0.7 mg in the morning \[AM\] + 0.3 mg in the evening \[PM\]), or as matching placebo BID.
MK-8226 BID, 1 mg
MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
Placebo BID (Panel A)
Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
Panel B: MK-8266 BID, 1.8 mg/Placebo
MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID.
MK-8266 BID, 1.8 mg
MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
Placebo BID (Panel B)
Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
Panel C: MK-8266 TID, 1.8 mg/Placebo
MK-8266 TID, 1.8 mg (0.6 mg every 6 hours \[q6hr\]), or as matching placebo TID.
MK-8266 TID, 1.8 mg
MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
Placebo TID (Panel C)
Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
Panel D: MK-8266 TID, 2.4 mg/Placebo
MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E.
MK-8266 TID, 2.4 mg
MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
Placebo TID (Panel D)
Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
Panel E: MK-8266 TID, 2.4 mg/Placebo
MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D.
MK-8266 TID, 2.4 mg
MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
Placebo TID (Panel E)
Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
Interventions
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MK-8226 BID, 1 mg
MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
MK-8266 BID, 1.8 mg
MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
MK-8266 TID, 1.8 mg
MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
MK-8266 TID, 2.4 mg
MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
MK-8266 TID, 2.4 mg
MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
Placebo BID (Panel A)
Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
Placebo BID (Panel B)
Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
Placebo TID (Panel C)
Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
Placebo TID (Panel D)
Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
Placebo TID (Panel E)
Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is in good general health (with the exception of hypertension)
* Participant has a Body Mass Index (BMI) \<= 33 kg/m\^2 at the Screening visit
* Participant has a platelet count \>= 150,000 cu/mL at the Screening visit
* Participant has a positive AIx at the Screening visit
Exclusion Criteria
* Participant has a functional disability that can interfere with rising from a seated position to the standing position
* Participant has any history of a bleeding or clotting disorder
* Participant has a history of cancer
* Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication
* Participant consumes excessive amounts of alcohol or caffeinated beverages daily
18 Years
55 Years
MALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2010-018654-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8266-002
Identifier Type: -
Identifier Source: org_study_id
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