A study to investigate MK-8150 in healthy, elderly subjects

• Research type

  Research Study

• Full title

  A Single Dose, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8150 in Healthy Elderly Male and Female Subjects

• IRAS ID

  112746

• Contact name

  Muna Albayaty

• Sponsor organisation

  Merck & Co., Inc.

• Eudract number

  2012-003586-17

• Research summary

  The new medicine tested in this study is a compound called MK-8150 which is being developed to treat isolated systolic hypertension (ISH) ?? ISH is a type of high blood pressure where only the systolic component of blood pressure (the upper number of a blood pressure reading - when the heart is contracting) is elevated. The diastolic component of blood pressure (the lower number of a blood pressure reading, when the heart is resting and filling with blood) remains normal or only slightly elevated. This is an open label (the investigators, clinic staff and the participants in this study will know that MK-8150 is being administered to all participants) study in healthy elderly male and female subjects, to assess the pharmacokinetics (how well the study drug is taken up, metabolised [chemically broken down], distributed through the body and excreted), safety and tolerability of a single oral dose of 6 mg MK-8150 (six 1 mg capsules). The pharmacodynamic results (what the drug does to the body) of certain vital signs such as blood pressure readings and heart rate will also be summarised. This will be the first time that MK-8150 will be administered to healthy, elderly subjects. MK-8150 has already been administered to 16 healthy young male participants in another increasing single dose study. A total of approximately 12 healthy, elderly male and female subjects will be included in this study (Panel A will include approximately 6 male volunteers and Panel B will include approximately 6 female volunteers). Blood samples for pharmacokinetic analysis will be collected and vital signs, safety ECG measurements, safety laboratory assessments (from blood and urine samples), adverse events (AEs) and concomitant medications will be monitored throughout the investigational period. This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0387

• Date of REC Opinion

  25 Sep 2012

• REC opinion

  Further Information Favourable Opinion