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

24 settembre 2018 aggiornato da: Merck Sharp & Dohme LLC

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening, or participated in another investigational study within 3 months prior to first dose of study drug
  • History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg
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.
Droga: MK-1064
Oral MK-1064 tablets (10 and 50 mg strengths)
Droga: MK-6096
Oral MK-6096 tablets (5 mg strength)
Droga: Placebo
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
Sperimentale: Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg
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.
Droga: MK-1064
Oral MK-1064 tablets (10 and 50 mg strengths)
Droga: MK-6096
Oral MK-6096 tablets (5 mg strength)
Droga: Placebo
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
Sperimentale: Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg
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.
Droga: MK-1064
Oral MK-1064 tablets (10 and 50 mg strengths)
Droga: MK-6096
Oral MK-6096 tablets (5 mg strength)
Droga: Placebo
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
Sperimentale: Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo
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.
Droga: MK-1064
Oral MK-1064 tablets (10 and 50 mg strengths)
Droga: MK-6096
Oral MK-6096 tablets (5 mg strength)
Droga: Placebo
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo
Lasso di tempo: 1 to 9 hours post dose, within each treatment period
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
Lasso di tempo: 1 to 9 hours post dose, within each treatment period
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)
Lasso di tempo: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
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
Lasso di tempo: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo
Lasso di tempo: 1 to 9 hours post dose, within each treatment period
WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.
1 to 9 hours post dose, within each treatment period
WASO Following Single Doses of MK-6096 and Placebo
Lasso di tempo: 1 to 9 hours post dose, within each treatment period
WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.
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
Lasso di tempo: Pre-dose and 10 hours post dose, within each treatment period
CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.
Pre-dose and 10 hours post dose, within each treatment period
Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo
Lasso di tempo: Pre-dose and 10 hours post dose, within each treatment period
CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.
Pre-dose and 10 hours post dose, within each treatment period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 novembre 2009

Completamento primario (Effettivo)

6 aprile 2010

Completamento dello studio (Effettivo)

6 aprile 2010

Date di iscrizione allo studio

Primo inviato

11 settembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

11 settembre 2015

Primo Inserito (Stima)

14 settembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 1064-003

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Dati/documenti di studio

  1. Sinossi CSR

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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