Conditions: Hypertension
Keywords: High blood pressure
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 31
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Treatment A in Period 1, Treatment B in Period 2, and Treatment C in Period 3 arm 2: Treatment A in Period 1, Treatment C in Period 2, and Treatment B in Period 3 arm 3: Treatment B in Period 1, Treatment C in Period 2, and Treatment A in Period 3 arm 4: Treatment B in Period 1, Treatment A in Period 2, and Treatment C in Period 3 arm 5: Treatment C in Period 1, Treatment A in Period 2, and Treatment B in Period 3 arm 6: Treatment C in Period 1, Treatment B in Period 2, and Treatment A in Period 3 arm 7: Treatment D in Period 1, Treatment E in Period 2, and Treatment F in Period 3 arm 8: Treatment D in Period 1, Treatment F in Period 2, and Treatment E in Period 3 arm 9: Treatment E in Period 1, Treatment F in Period 2, and Treatment D in Period 3 arm 10: Treatment E in Period 1, Treatment D in Period 2, and Treatment F in Period 3 arm 11: Treatment F in Period 1, Treatment D in Period 2, and Treatment E in Period 3 arm 12: Treatment F in Period 1, Treatment E in Period 2, and Treatment D in Period 3

Interventions: intervention 1: Treatment A intervention 2: Treatment B intervention 3: Treatment C intervention 4: Treatment D intervention 5: Treatment E intervention 6: Treatment F
Intervention descriptions: intervention 1: MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 2: MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 3: Placebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266. intervention 4: MK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 5: MK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 6: Placebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.

Protocol document: