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

NCT ID: NCT01092780

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-26
• Study Completion Date: 2011-05-31

Brief Summary

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).

Conditions

Apnea, Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

MK-7288

Intervention Type: DRUG

one or two 10 mg capsules, orally, single dose

Placebo to MK-7288

Intervention Type: DRUG

one or two capsules, orally, single dose

Modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

Placebo to modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

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

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.

Group Type: EXPERIMENTAL

MK-7288

Intervention Type: DRUG

one or two 10 mg capsules, orally, single dose

Placebo to MK-7288

Intervention Type: DRUG

one or two capsules, orally, single dose

Modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

Placebo to modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

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

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.

Group Type: EXPERIMENTAL

MK-7288

Intervention Type: DRUG

one or two 10 mg capsules, orally, single dose

Placebo to MK-7288

Intervention Type: DRUG

one or two capsules, orally, single dose

Modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

Placebo to modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

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

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.

Group Type: EXPERIMENTAL

MK-7288

Intervention Type: DRUG

one or two 10 mg capsules, orally, single dose

Placebo to MK-7288

Intervention Type: DRUG

one or two capsules, orally, single dose

Modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

Placebo to modafinil

Intervention Type: DRUG

two 100 mg tablets, orally, single dose

Interventions

MK-7288

one or two 10 mg capsules, orally, single dose

Intervention Type: DRUG

Placebo to MK-7288

one or two capsules, orally, single dose

Intervention Type: DRUG

Modafinil

two 100 mg tablets, orally, single dose

Intervention Type: DRUG

Placebo to modafinil

two 100 mg tablets, orally, single dose

Intervention Type: DRUG

Other Intervention Names

PROVIGIL®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Sun H, MacLeod C, Mostoller K, Mahon C, Han L, Renger JJ, Ma J, Brown KR, Schulz V, Kay GG, Herring WJ, Lines C, Rosen LB, Murphy MG, Wagner JA. Early-stage comparative effectiveness: randomized controlled trial with histamine inverse agonist MK-7288 in excessive daytime sleepiness patients. J Clin Pharmacol. 2013 Dec;53(12):1294-302. doi: 10.1002/jcph.182. Epub 2013 Oct 4.

Reference Type: RESULT

PMID: 24122944 (View on PubMed)

Other Identifiers

MK-7288-010

Identifier Type: OTHER

Identifier Source: secondary_id

7288-010

Identifier Type: -

Identifier Source: org_study_id