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MK-7252

Phase 1

Pharmacokinetics | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jan 9, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

MK-7252 · 1 trial · 2 indications

Phase 1 1
NCT03326986Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)Pharmacokinetics
COMPLETED24 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)
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Study Endpoints

Primary Endpoints

Number of Participants Who Experienced at Least One Adverse Event (AE)
Up to approximately 21 weeks

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have had a causal relationship with this treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. Adverse events are reported by dose taken at time of event and not by panel or period. The adverse events for placebo are pooled over periods across panels. The number of participants who experienced at least one AE is presented.

Number of Participants Who Discontinued Study Treatment Due to an AE
Up to approximately 19 weeks

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have had a causal relationship with this treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. Discontinuations are reported by dose taken at time of event. The discontinuations for placebo are pooled over periods across panels. The number of participants who discontinued study treatment due to an AE is presented.

Secondary Endpoints

MK-7252 Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞)
Predose (Day 1) and 0.25, 0.5, 1, 2, 4, 8, 10, 12, 24, 48, and 72 hours postdose
MK-7252 Area Under the Concentration-Time Curve From Zero to 24 Hours Postdose (AUC0-24hr)
Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, 12, and 24 hours postdose
MK-7252 Area Under the Concentration-Time Curve From Zero to 12 Hours Postdose (AUC0-12hr)
Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, and 12 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panel AEXPERIMENTALParticipants receive either a single dose of MK-7252 or Placebo in a fasted state in each of five alternating treatment dosing periods as indicated. The planned dose levels include: Placebo for MK-7252, 1 mg of MK-7252, 6 mg of MK-7252, 24 mg of MK-7252, 72 mg of MK-7252, and 108 mg of MK-7252. There is a minimum of a 7-day washout period between each treatment period or dose administration. The planned dose levels may be adjusted downward or replaced based on evaluation of safety, tolerability, pharmacokinetic and/or pharmacodynamic data observed after previous treatment periods
Panel BEXPERIMENTALParticipants receive either a single dose of MK-7252 or Placebo in a fasted state in each of five alternating treatment dosing periods as indicated. The planned dose levels include: Placebo for MK-7252, 3 mg of MK-7252, 12 mg of MK-7252, 48 mg of MK-7252, 72 mg of MK-7252, and 162 mg of MK-7252. There is a minimum of a 7-day washout period between each treatment period or dose administration. The planned dose levels may be adjusted downward or replaced based on evaluation of safety, tolerability, pharmacokinetic and/or pharmacodynamic data observed after previous treatment periods
Panel CEXPERIMENTALParticipants receive either a single dose of MK-7252 or Placebo in up to 5 treatment dosing periods as indicated: Placebo for MK-7252, 120 mg of MK-7252 in a fasted state, 240 mg of MK-7252, 360 mg of MK-7252, 540 mg of MK-7252, and 120 mg of MK-7252 in a fed state. There is a minimum of a 7-day washout period between each treatment period or dose administration. The planned dose levels may be adjusted downward or replaced based on evaluation of safety, tolerability, pharmacokinetic and/or pharmacodynamic data observed after previous treatment periods

Interventions

NameTypeDescription
MK-7252DRUG1 mg/mL or 20 mg/mL of powder for oral suspension administered with a water volume that brings the total ingested volume to approximately 240 mL
PlaceboDRUGPlacebo powder for oral suspension administered with a water volume that brings the total ingested volume to approximately 240 mL
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female participants of non-childbearing potential (Note: If postmenopausal female: participant is without menses for at least 1 year and has a documented follicle stimulating hormone \[FSH\] level in the postmenopausal range at pre-trial \[screening\] - OR - If surgica...

Countries:Belgium
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Frequently asked questions about MK-7252

What is MK-7252?

MK-7252 is an investigational small molecule being developed by Merck & Company, Inc. for oncology indications. It is currently in Phase 1 clinical development, with studies focused on evaluating its pharmacokinetics in healthy adult participants.

What is MK-7252 used for?

MK-7252 is being studied for use in oncology, specifically to evaluate its pharmacokinetics. A completed Phase 1 trial assessed its safety, tolerability, and pharmacokinetics in healthy adult participants, with cancer listed as a condition of interest.

Who makes MK-7252?

MK-7252 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile.

What phase is MK-7252 in?

MK-7252 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is MK-7252 in?

MK-7252 has one completed clinical trial, NCT03326986, titled "Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)." This Phase 1 study enrolled 24 participants in Belgium and was a randomized, double-blind, controlled trial.