Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Apnea, Sleep

Treatments: Drug: Placebo to modafinil; Drug: Modafinil; Drug: Placebo to MK-7288; Drug: MK-7288

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092780

MK-7288-010 (Other Identifier)

7288-010

Details and patient eligibility

About

This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the effect of MK-7288 after single dose administration on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).

Enrollment: 56 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participants are of non-child-bearing potential.
• Male participants who have female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study.
• Participant has an International Classification of Sleep Disorders diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome.
• Participant has excessive daytime sleepiness.
• Participant has been using nCPAP treatment for at least 2 months.
• Participant reported total sleep time of >6 hours on at least 4 out of 7 nights each week
• Participant is willing to stay at the sleep laboratory for 5 overnight stays.
• Participant is willing to limit caffeine and alcohol consumption during the study.
• Participant has a valid driver's license in the past 5 years and has had at least 1 year of driving experience within the past 3 years.
• Participant's regular bedtime is between 9:00 p.m. and 12:00 a.m.

Exclusion criteria

• Participant has a history of cancer.
• Participant has any history of a significant neurological disorder.
• Participant has moderate or severe persistent asthma.
• Participant has a history of any of the following sleep disorders: narcolepsy, primary insomnia, Circadian rhythm sleep disorder, shift work sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, rapid eye movement (REM) behavioral disorder, and sleepwalking disorder, periodic limb movement disorder, or restless leg syndrome.
• Participant consumes more than 10 cigarettes a day or routinely smokes during the night.
• Participant, in the opinion of the investigator, has a history or current evidence of any condition, therapy, lab abnormality or circumstances that might confound the results of the study, or interfere with participation for the full duration of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 4 patient groups

MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil

Experimental group

Description:

Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.

Treatment:

Drug: Placebo to MK-7288

Drug: Modafinil

Drug: MK-7288

Drug: Placebo to modafinil

MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo

Experimental group

Description:

Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.

Treatment:

Drug: Placebo to MK-7288

Drug: Modafinil

Drug: MK-7288

Drug: Placebo to modafinil

Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg

Experimental group

Description:

Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.

Treatment:

Drug: Placebo to MK-7288

Drug: Modafinil

Drug: MK-7288

Drug: Placebo to modafinil

Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg

Experimental group

Description:

Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.

Treatment:

Drug: Placebo to MK-7288

Drug: Modafinil

Drug: MK-7288

Drug: Placebo to modafinil