PharmacokineticsPhase 1NCT02549014

A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001)

A Phase 1 study testing MK-1064 in people with Pharmacokinetics, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: MK-1064
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: No sites listed yet
Study dates: 6 Jul 2009to 29 Sep 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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 approximately 6 months

Who cannot join

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 legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast

Show all 17Show fewer

History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease 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) or participated in another investigational study within 4 weeks prior to screening
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
Is a regular user of sedative-hypnotic agents

About this study

Official title: A Single Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064

The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064 plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment of MK-1064 in humans, the study protocol allows for modifications to the outlined dose, dosing regimen and/or clinical or laboratory procedures, if required to address study objectives and/or to ensure appropriate safety monitoring of participants.

Read the detailed description

Two panels (Panels A and B), will receive alternating single rising oral doses of MK-1064/placebo (i.e., order of administration will be Panel A 5 mg, Panel B 10 mg, Panel A 25 mg, Panel B 50 mg, and continuing in this alternating sequence). Following dosing for a given treatment period, a minimum of 3 days will elapse before administration of the next scheduled dose. After administration of each dose, safety and tolerability will be reviewed. The decision to proceed to the next Panel/Period in the alternating sequence will be contingent on acceptable safety and tolerability data from the preceding Panels/Periods.

Conditions: Pharmacokinetics
Being tested: MK-1064, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-1064Drug
Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths)
PlaceboDrug
Dose for each period administered as oral placebo tablets matching active MK-1064 tablets

Study groups in NCT02549014
Study group	Role	What they receive
Panel A: MK-1064 5 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel B: MK-1064 10 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel A: MK-1064 25 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel B: MK-1064 50 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel A: MK-1064 100 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel B: MK-1064 150 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel A: MK-1064 200 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel B: MK-1064 250 mg	Experimental	Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: MK-1064
Panel A: MK-1064 25 mg (Fed)	Experimental	In Period 5, participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast. Receives: Drug: MK-1064
Panel B: MK-1064 50 mg (Night)	Experimental	In Period 5, participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast. Receives: Drug: MK-1064
Panels A & B: Placebo	Placebo comparator	Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced One or More 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 study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Measured: Up to 14 days after the last dose of study drug (Up to approximately 60 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 study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Measured: Up to 14 days after the last dose of study drug (Up to approximately 60 days)
Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064
AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.
Measured: Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose

Secondary outcomes (4)

Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064
AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)
Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064
Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Time to Cmax (Tmax) Following Single Doses of MK-1064
Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064
t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 200929 Sep 2009

First posted14 Sep 2015 (estimated)
Study start6 Jul 2009
Primary completion29 Sep 2009
Study completion29 Sep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02549014
Sponsor's protocol ID: 1064-001
Status last verified: Sep 2018
First submitted: 11 Sep 2015
Last updated: 23 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pharmacokinetics trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064
ClinicalTrials.gov ID: NCT02549014
Acronym / sponsor ID: 1064-001
Conditions: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Jul 2009 (actual)
Primary completion: 29 Sep 2009 (actual)
Study completion: 29 Sep 2009 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 21 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 11

Arm	Type	Receives
Panel A: MK-1064 5 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel B: MK-1064 10 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel A: MK-1064 25 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel B: MK-1064 50 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel A: MK-1064 100 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel B: MK-1064 150 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel A: MK-1064 200 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel B: MK-1064 250 mg	Experimental	Drug: MK-1064Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Panel A: MK-1064 25 mg (Fed)	Experimental	Drug: MK-1064In Period 5, participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
Panel B: MK-1064 50 mg (Night)	Experimental	Drug: MK-1064In Period 5, participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
Panels A & B: Placebo	Placebo comparator	Drug: PlaceboWithin each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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 approximately 6 months

Key exclusion criteria (17 listed)

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 legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-1064Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths)	Drug	Panel A: MK-1064 100 mg, Panel A: MK-1064 200 mg, Panel A: MK-1064 25 mg, Panel A: MK-1064 25 mg (Fed), Panel A: MK-1064 5 mg, Panel B: MK-1064 10 mg, Panel B: MK-1064 150 mg, Panel B: MK-1064 250 mg, Panel B: MK-1064 50 mg, Panel B: MK-1064 50 mg (Night)
PlaceboDose for each period administered as oral placebo tablets matching active MK-1064 tablets	Drug	Panels A & B: Placebo

Primary outcome

Number of Participants Who Experienced One or More Adverse Events (AEs)
Time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 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 study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Number of Participants Who Discontinued Study Due to an AE
Time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 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 study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064
Time frame: Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose
AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.

4 secondary outcomes

Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)
Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Time to Cmax (Tmax) Following Single Doses of MK-1064
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)

Results and safety

Results posted to the registry on 21 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel A: MK-1064	8	8
Panel B: MK-1064	8	8

Primary outcome: Number of Participants Who Experienced One or More Adverse Events (AEs)

Time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 days). Number. Unit: Participants

Measure	Panel A: MK-1064 5 mg n = 6	Panel B: MK-1064 10 mg n = 6	Panel A: MK-1064 25 mg n = 6	Panel B: MK-1064 50 mg n = 6	Panel A: MK-1064 100 mg n = 6	Panel B: MK-1064 150 mg n = 6	Panel A: MK-1064 200 mg n = 6	Panel B: MK-1064 250 mg n = 6	Panel A: MK-1064 25 mg (Fed) n = 6	Panel B: MK-1064 50 mg (Night) n = 6	Panels A & B: Placebo n = 16
Value	4	5	5	5	5	5	6	6	3	3	5

Population analysed: All participants who received ≥1 dose of study drug.

Primary outcome: Number of Participants Who Discontinued Study Due to an AE

Time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 days). Number. Unit: Participants

Measure	Panel A: MK-1064 5 mg n = 6	Panel B: MK-1064 10 mg n = 6	Panel A: MK-1064 25 mg n = 6	Panel B: MK-1064 50 mg n = 6	Panel A: MK-1064 100 mg n = 6	Panel B: MK-1064 150 mg n = 6	Panel A: MK-1064 200 mg n = 6	Panel B: MK-1064 250 mg n = 6	Panel A: MK-1064 25 mg (Fed) n = 6	Panel B: MK-1064 50 mg (Night) n = 6	Panels A & B: Placebo n = 16
Value	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All participants who received ≥1 dose of study drug.

Primary outcome: Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064

Time frame: Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose. Geometric mean (Standard Deviation). Unit: µmol*hr/L

Measure	Panel A: MK-1064 5 mg n = 6	Panel B: MK-1064 10 mg n = 6	Panel A: MK-1064 25 mg n = 6	Panel B: MK-1064 50 mg n = 6	Panel A: MK-1064 100 mg n = 6	Panel B: MK-1064 150 mg n = 6	Panel A: MK-1064 200 mg n = 6	Panel B: MK-1064 250 mg n = 6	Panel A: MK-1064 25 mg (Fed) n = 6	Panel B: MK-1064 50 mg (Night) n = 6	Panels A & B: Placebo n = 0
Value	0.77 (0.13)	1.01 (0.42)	2.99 (0.41)	5.51 (2.29)	9.75 (1.31)	10.28 (3.42)	20.12 (9.03)	22.70 (7.98)	1.61 (0.25)	5.16 (2.60)	–

Population analysed: All participants who received ≥1 dose of MK-1064.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel A: MK-1064 5 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Panel B: MK-1064 10 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Panel A: MK-1064 25 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Panel B: MK-1064 50 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Panel A: MK-1064 100 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Panel B: MK-1064 150 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Panel A: MK-1064 200 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
Panel B: MK-1064 250 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
Panel A: MK-1064 25 mg (Fed)	1 of 6 (16.7%)	3 of 6 (50%)	Not reported
Panel B: MK-1064 50 mg (Night)	0 of 6 (0%)	3 of 6 (50%)	Not reported
Panels A & B: Placebo	0 of 16 (0%)	5 of 16 (31.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-1064 in people with Pharmacokinetics, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced One or More Adverse Events (AEs) (time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02549014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.