Human Immunodeficiency Virus-1 (HIV-1)Phase 1NCT02549040

Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)

A Phase 1 study testing Treatment A: Doravirine 100 mg film coated tablet, Treatment B: Doravirine 150 mg tablet (40% drug loaded granule) and Treatment C: Doravirine 150 mg tablet (30% drug loaded granule) in people with Human Immunodeficiency Virus-1 (HIV-1), 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

This study aims to evaluate and compare the relative bioavailability of different doravirine (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus-1 (HIV-1)
What is being tested?: Treatment A: Doravirine 100 mg film coated tablet, Treatment B: Doravirine 150 mg tablet (40% drug loaded granule) and Treatment C: Doravirine 150 mg tablet (30% drug loaded granule)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: No sites listed yet
Study dates: 21 Sep 2015to 24 Dec 2015
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy participants
have been a non-smoker and/or have not used nicotine or nicotine-containing products for at least approximately 3 months

Who cannot join

is a pregnant or a nursing female
has a history of stroke, chronic seizures or major neurological disorder
has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease

About this study

Official title: A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults

This study aims to evaluate and compare the relative bioavailability of different doravirine (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet.

Conditions: Human Immunodeficiency Virus-1 (HIV-1)
Being tested: Treatment A: Doravirine 100 mg film coated tablet, Treatment B: Doravirine 150 mg tablet (40% drug loaded granule), Treatment C: Doravirine 150 mg tablet (30% drug loaded granule), Treatment D: Doravirine 150 mg tablet (50% drug loaded granule), Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)

What participants receive

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

Treatment A: Doravirine 100 mg film coated tabletDrug
Also called MK-1439
Single doravirine 100 mg film coated tablet administered orally at the start of Period 2
Treatment B: Doravirine 150 mg tablet (40% drug loaded granule)Drug
Also called MK-1439
Single doravirine NF Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1
Treatment C: Doravirine 150 mg tablet (30% drug loaded granule)Drug
Also called MK-1439
Single doravirine NF Type 2 dose (150 mg tablet [30% drug loaded granule])administered orally at the start of Period 3
Treatment D: Doravirine 150 mg tablet (50% drug loaded granule)Drug
Also called MK-1439
Single doravirine NF Type 3 dose (150 mg tablet [50% drug loaded granule])administered orally at the start of Period 4
Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)Drug
Also called MK-1439
Single doravirine NF Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5

Study groups in NCT02549040
Study group	Role	What they receive
Doravirine fixed sequence treatment	Experimental	After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: Doravirine Type 1 dose (150 mg tablet [40% drug loaded granule]). During Period 2, participants received Treatment A: Doravirine 100 mg film coated tablet. During Period 3, participants received Treatment C: Doravirine Type 2 dose (150 mg tablet [30% drug loaded granule]). During Period 4, participants received Treatment D: Doravirine Type 3 dose (150 mg tablet [50% drug loaded granule]. During Period 5, participants received Treatment E: Doravirine Type 4 dose (100 mg tablet [30% drug loaded granule]). Each period was separated by a 14 day washout. Receives: Drug: Treatment A: Doravirine 100 mg film coated tablet; Drug: Treatment B: Doravirine 150 mg tablet (40% drug loaded granule); Drug: Treatment C: Doravirine 150 mg tablet (30% drug loaded granule); Drug: Treatment D: Doravirine 150 mg tablet (50% drug loaded granule); Drug: Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)

What is being measured

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

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-inf after a single administration of MK-1439.
Measured: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time 0 to Last Time (AUC0-last) With Quantifiable MK-1439 Following a Single Administration of MK-1439
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-last after a single administration of MK-1439.
Measured: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose to determine Cmax after a single administration of MK-1439.
Measured: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439
During each of the 5 treatment periods, blood samples were collected 24 hours after dosing to determine C24hr after a single administration of MK-1439.
Measured: Periods 1 to 5: 24 hours post-dose
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Measured: Up to 16 days after last dose of study treatment (up to approximately 92 days)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Measured: Up to 4 days after last dose of study treatment (up to approximately 76 days)

Secondary outcomes (1)

Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48 hr) Post-dose of MK-1439 Following a Single Administration of MK-1439
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48 hours after dosing to determine AUC0-48hr after a single administration of MK-1439.
Measured: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours post-dose

Timeline

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

21 Sep 201524 Dec 2015

First posted14 Sep 2015 (estimated)
Study start21 Sep 2015
Primary completion24 Dec 2015
Study completion24 Dec 2015

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 Human Immunodeficiency Virus-1 (HIV-1)Studies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02549040
Sponsor's protocol ID: 1439-046
Other IDs: 2015-002702-36, MK-1439-046, 2015
Status last verified: Dec 2020
First submitted: 11 Sep 2015
Last updated: 7 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults
ClinicalTrials.gov ID: NCT02549040
Acronym / sponsor ID: 1439-046
Conditions: Human Immunodeficiency Virus-1 (HIV-1)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 21 Sep 2015 (actual)
Primary completion: 24 Dec 2015 (actual)
Study completion: 24 Dec 2015 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 22 Feb 2019

Clinical summary

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

This study aims to evaluate and compare the relative bioavailability of different doravirine (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Doravirine fixed sequence treatment	Experimental	Drug: Treatment A: Doravirine 100 mg film coated tablet, Drug: Treatment B: Doravirine 150 mg tablet (40% drug loaded granule), Drug: Treatment C: Doravirine 150 mg tablet (30% drug loaded granule), Drug: Treatment D: Doravirine 150 mg tablet (50% drug loaded granule), Drug: Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: Doravirine Type 1 dose (150 mg tablet [40% drug loaded granule]). During Period 2, participants received Treatment A: Doravirine 100 mg film coated tablet. During Period 3, participants received Treatment C: Doravirine Type 2 dose (150 mg tablet [30% drug loaded granule]). During Period 4, participants received Treatment D: Doravirine Type 3 dose (150 mg tablet [50% drug loaded granule]. During Period 5, participants received Treatment E: Doravirine Type 4 dose (100 mg tablet [30% drug loaded granule]). Each period was separated by a 14 day washout.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

healthy participants
have been a non-smoker and/or have not used nicotine or nicotine-containing products for at least approximately 3 months

Key exclusion criteria (4 listed)

is a pregnant or a nursing female
has a history of stroke, chronic seizures or major neurological disorder
has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease

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
Treatment A: Doravirine 100 mg film coated tabletAlso: MK-1439Single doravirine 100 mg film coated tablet administered orally at the start of Period 2	Drug	Doravirine fixed sequence treatment
Treatment B: Doravirine 150 mg tablet (40% drug loaded granule)Also: MK-1439Single doravirine NF Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1	Drug	Doravirine fixed sequence treatment
Treatment C: Doravirine 150 mg tablet (30% drug loaded granule)Also: MK-1439Single doravirine NF Type 2 dose (150 mg tablet [30% drug loaded granule])administered orally at the start of Period 3	Drug	Doravirine fixed sequence treatment
Treatment D: Doravirine 150 mg tablet (50% drug loaded granule)Also: MK-1439Single doravirine NF Type 3 dose (150 mg tablet [50% drug loaded granule])administered orally at the start of Period 4	Drug	Doravirine fixed sequence treatment
Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)Also: MK-1439Single doravirine NF Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5	Drug	Doravirine fixed sequence treatment

Primary outcome

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439
Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-inf after a single administration of MK-1439.
Area Under the Plasma Concentration-time Curve From Time 0 to Last Time (AUC0-last) With Quantifiable MK-1439 Following a Single Administration of MK-1439
Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-last after a single administration of MK-1439.
Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439
Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose to determine Cmax after a single administration of MK-1439.
Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439
Time frame: Periods 1 to 5: 24 hours post-dose
During each of the 5 treatment periods, blood samples were collected 24 hours after dosing to determine C24hr after a single administration of MK-1439.
Number of Participants Who Experienced at Least One Adverse Event
Time frame: Up to 16 days after last dose of study treatment (up to approximately 92 days)
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
Time frame: Up to 4 days after last dose of study treatment (up to approximately 76 days)
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

1 secondary outcome

Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48 hr) Post-dose of MK-1439 Following a Single Administration of MK-1439
Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours post-dose

Results and safety

Results posted to the registry on 22 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-1439 Fixed Sequence Treatment	16	16

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439

Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: µM*h

Measure	Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) n = 13	Treatment A: MK-1439 100 mg Film Coated Tablet n = 16	Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule) n = 15	Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule) n = 12	Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule) n = 15
Value	28.6 (34.6)	31.9 (33.9)	35.5 (29.6)	29.1 (30.3)	28.0 (27.5)

Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) vs Treatment A: MK-1439 100 mg Film Coated Tablet: Geometric mean ratio: 0.96 (90% CI 0.85 to 1.09)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule): Geometric mean ratio: 1.13 (90% CI 1.02 to 1.26)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule): Geometric mean ratio: 0.99 (90% CI 0.88 to 1.11)

Population analysed: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model. Participants were excluded from descriptive statistics for AUC0-inf if there were insufficient data in the terminal phase to characterize half-life (t1/2).

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to Last Time (AUC0-last) With Quantifiable MK-1439 Following a Single Administration of MK-1439

Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: μM*h

Measure	Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) n = 16	Treatment A: MK-1439 100 mg Film Coated Tablet n = 16	Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule) n = 16	Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule) n = 16	Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule) n = 16
Value	26.3 (29.3)	29.9 (31.1)	32.7 (26.3)	27.0 (28.4)	26.3 (27.0)

Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) vs Treatment A: MK-1439 100 mg Film Coated Tablet: Geometric mean ratio: 0.88 (90% CI 0.79 to 0.98)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule): Geometric mean ratio: 1.09 (90% CI 0.98 to 1.21)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule): Geometric mean ratio: 0.90 (90% CI 0.81 to 1.00)

Population analysed: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.

Primary outcome: Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439

Time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nM

Measure	Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) n = 16	Treatment A: MK-1439 100 mg Film Coated Tablet n = 16	Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule) n = 16	Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule) n = 16	Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule) n = 16
Value	1070 (26.5)	1520 (32.5)	1320 (27.8)	1060 (27.0)	1160 (24.2)

Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) vs Treatment A: MK-1439 100 mg Film Coated Tablet: Geometric mean ratio: 0.70 (90% CI 0.61 to 0.82)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule): Geometric mean ratio: 0.87 (90% CI 0.75 to 1.01)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule): Geometric mean ratio: 0.70 (90% CI 0.60 to 0.81)

Population analysed: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.

Primary outcome: Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439

Time frame: Periods 1 to 5: 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nM

Measure	Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) n = 16	Treatment A: MK-1439 100 mg Film Coated Tablet n = 16	Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule) n = 16	Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule) n = 16	Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule) n = 16
Value	395 (31.9)	483 (33.3)	508 (23.2)	412 (28.0)	402 (32.0)

Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule) vs Treatment A: MK-1439 100 mg Film Coated Tablet: Geometric mean ratio: 0.82 (90% CI 0.72 to 0.93)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule): Geometric mean ratio: 1.05 (90% CI 0.94 to 1.18)
Treatment A: MK-1439 100 mg Film Coated Tablet vs Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule): Geometric mean ratio: 0.85 (90% CI 0.76 to 0.96)

Population analysed: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 16 days following the last dose of study treatment (up to approximately 92 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
Treatment A: MK-1439 100 mg Film Coated Tablet	0 of 16 (0%)	5 of 16 (31.3%)	0 of 16
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)	0 of 16 (0%)	4 of 16 (25%)	0 of 16
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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?

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 2 inclusion and 4 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 7 Jan 2021. 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. 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 22 Feb 2019). 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?

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439 (time frame: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose). The study lists 6 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 NCT02549040.

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 7 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.