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MK-8583

Phase 1

HIV-1 Infection | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Mar 4, 2020

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 Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03552536MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)PHASE1 COMPLETED 5Oct 7, 2018Mar 11, 2019Mar 4, 20201 Germany
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Study Endpoints
Primary Endpoints
Number of Participants With at Least One Adverse Event (AE)
Up to Day 29

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Number of Participants Who Discontinued Study Due to an AE
Day 1

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at 168 Hours Post-dose.
Baseline (pre-dose) and 168 hours post-dose.

Plasma HIV-1 RNA was measured at baseline and 168 hours after dosing. Change from baseline for MK-8583 at 168 hours post-baseline was estimated from longitudinal data analysis (LDA) model containing fixed effects for time (predose, 168 hours postdose) and a random effect for participant. The change from baseline in plasma HIV-1 RNA in participants administered MK-8583 was compared with historical placebo data.

Secondary Endpoints
Area Under the Concentration Time Curve From Time 0-168 Hours Postdose (AUC0-168hr) of Tenofovir Diphosphate (TFV-DP)
Pre-dose, 4, 12, 24, 48, 72, 96, and 168 hours postdose
Time to Achieve Maximum Concentration (Tmax) of TFV-DP
Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose
Maximum Concentration (Cmax) of TFV-DP
Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A: MK-8583 100mgEXPERIMENTALAfter fasting, a single oral dose of 100 mg MK-8583 in capsule form.
B: MK-8583 ≤ 150 mgEXPERIMENTALAfter fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form, with the dose based on the results from earlier treatments
C: MK-8583 ≤ 150 mgEXPERIMENTALAfter fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form, with the dose based on the results from earlier treatments
Interventions
NameTypeDescription
MK-8583DRUGA single oral dose of MK-8583 in capsule form
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male with female partner(s) of child-bearing potential use required methods of birth control. * Female of reproductive potential must demonstrate a nongravid state at the pretrial (screening) visit and agree to use acceptable methods of birth control beginning at the pretrial ...

Countries:Germany
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