A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)

NCT02549027 | Completed Phase 1 Results

• 1 other identifier: 1064-003
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.

Conditions

Polysomnography

Outcome Measures

Primary Outcomes (4)

• Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo

  LPS is measured during overnight sleep laboratory (polysomnography \[PSG\]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.

  1 to 9 hours post dose, within each treatment period

• LPS Following Single Doses of MK-6096 and Placebo

  LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.

  1 to 9 hours post dose, within each treatment period

• Number of Participants With Adverse Events (AEs)

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.

  Up to 14 days after the last dose of study drug (Up to approximately 42 days)

• Number of Participants Who Discontinued Study Due to an AE

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.

  Up to 14 days after the last dose of study drug (Up to approximately 42 days)

Secondary Outcomes (4)

• Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo

  1 to 9 hours post dose, within each treatment period

• WASO Following Single Doses of MK-6096 and Placebo

  1 to 9 hours post dose, within each treatment period

• Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo

  Pre-dose and 10 hours post dose, within each treatment period

• Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo

  Pre-dose and 10 hours post dose, within each treatment period

Study Arms (4)

Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg

EXPERIMENTAL

For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.

Drug: MK-1064; Drug: MK-6096; Drug: Placebo

Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg

EXPERIMENTAL

For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.

Drug: MK-1064; Drug: MK-6096; Drug: Placebo

Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg

EXPERIMENTAL

For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.

Drug: MK-1064; Drug: MK-6096; Drug: Placebo

Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo

EXPERIMENTAL

For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.

Drug: MK-1064; Drug: MK-6096; Drug: Placebo

Interventions

MK-1064 DRUG

Oral MK-1064 tablets (10 and 50 mg strengths)

Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg; Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo; Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg; Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg

MK-6096 DRUG

Oral MK-6096 tablets (5 mg strength)

Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg; Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo; Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg; Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg

Placebo DRUG

Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)

Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg; Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo; Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg; Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) ≤31 kg/m\^2
• In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
• Nonsmoker and has not used nicotine or nicotine-containing products for at least 6 months
• No history of any sleep disorder
• Has not used prescription or over the counter sedation or alerting medication in 4 weeks prior to screening
• Participant has a usual bedtime between 8:00 PM and 12:00 AM
• Participant has total sleep duration of ≥6.5 and ≤9 hours during the 4 weeks prior to screening
• Male participants with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug

You may not qualify if:

• Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
• History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless leg syndrome, or narcolepsy
• History of clinically significant sleep disorders within the last 5 years
• History of circadian rhythm sleep disorder, clinically important parasomnia, or primary insomnia
• History of repeated falls or fractures secondary to falling within the past 2 years
• Participant works a night shift and is not able to avoid night shift work a minimum of 1 week prior to screening and for the duration of the study
• Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
• Is a regular user of sedative-hypnotic agents
• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of stroke, peripheral neuropathy, chronic seizures or other clinically significant neurological disorder or cognitive impairment
• History of cancer
• History of cataplexy
• Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
• Participant consumes \>3 servings of alcohol a day
• Participant consumes \>6 caffeine servings a day

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Interventions

MK-6096

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 14, 2015
• Study Start: November 6, 2009
• Primary Completion: April 6, 2010
• Study Completion: April 6, 2010
• Last Updated: October 23, 2018
• Results First Posted: December 10, 2015

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share