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MK-8504

Phase 1

HIV-1 Infection | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jul 15, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03188523Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)PHASE1 COMPLETED 12Sep 8, 2017Jun 4, 2018Jul 15, 20192 Germany, United Kingdom
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Study Endpoints
Primary Endpoints
Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) at 168 Hours Post-Dose
Baseline, 168 hours post-dose

Plasma samples were collected from participants after a single dose of MK-8504 to assess viral load. The log10 plasma HIV-RNA (copies/mL) measurements from participants in each panel were pooled and analyzed based on a longitudinal data analysis model. Change from baseline to 168 hours post-dose was determined for each treatment group. Results are expressed as change in HIV RNA log10 (copies/mL).

Number of Participants Who Experienced At Least One Adverse Event (AE)
From Day 1 through Post-Trial Visit (up to 25 days)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants experiencing at least one AE was reported for each arm.

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Day 1

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants that discontinued study treatment due to an AE was reported for each arm.

Secondary Endpoints
Area Under the Concentration-Time Curve of MK-8504 in Plasma From Time 0 to Last Measurable Concentration (AUC0-last)
Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose
Area Under the Concentration-Time Curve of MK-8504 in Plasma From Time 0 to Infinity (AUC0-inf)
Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose
Area Under the Concentration-Time Curve of MK-8504 in Plasma From Time 0 to 168 Hours (AUC0-168hr)
Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-8504 100 mg (Panel A)EXPERIMENTALParticipants receive a single oral dose of MK-8504 100 mg.
MK-8504 240 mg (Panel B)EXPERIMENTALParticipants receive a single oral dose of MK-8504 240 mg.
MK-8504 ≤240 mg (Panel C)EXPERIMENTALParticipants receive a single oral dose of MK-8504 ≤240 mg.
MK-8504 ≤240 mg (Panel D)EXPERIMENTALParticipants receive a single oral dose of MK-8504 ≤240 mg.
Interventions
NameTypeDescription
MK-8504DRUGAfter at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or non-pregnant and non-breast feeding female * Have a Body Mass Index (BMI) ≤35 kg/m\^2 * Other than HIV infection, have stable baseline health based on medical history, physical examination, vital sign measurements, and laboratory safety test * Is documented HIV-1 posit...

Countries:GermanyUnited Kingdom
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