Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)
Condition: Pharmacokinetics; Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five
      treatment periods. Each treatment period is separated by a 7-day washout period.

      Upon review of the interim safety and preliminary PK data of human exposure to date, Protocol
      Amendment 3 includes a third panel of participants, Panel C, to assess the PK of higher doses
      of MK-7252 and to assess the food effect of MK-7252.
    

Detailed description: 
      Three panels (Panels A, B, and C) of 8 healthy participants (n=6 MK-7252, n=2 placebo) are
      enrolled. In Panels A and B, participants will alternately receive single rising doses of
      MK-7252 or placebo for 5 treatment periods. In Panel C, participants will receive single
      rising doses of MK-7252 or placebo for up to 5 treatment periods. All doses in Panels A and B
      will be administered in the fasted state during the 5 treatment periods. Doses in Panel C
      will be administered in a fasted state in treatment periods 1 through 4 and the treatment
      period 1 dose will be repeated in a fed state during treatment period 5. Panel A will begin
      first. At least 3 days will elapse before participants in Panel B will receive the next
      higher dose. For all panels, there will be at least 7 days washout between treatment periods
      for any given participant. Participants may only be enrolled in one panel of the study. 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. All participants in the treatment periods of all panels (with exception of 120 mg
      fasted/fed periods in Panel C) will be randomly assigned to either study drug or placebo;
      that is a participant could be assigned to receive study drug in one period and placebo in
      another. As per the protocol allocation plan, the same participants in Panel C will receive
      120 mg MK-7252 in a fasted and fed state. In addition, during any of the treatment periods if
      a participant demonstrates change in any one of the protocol-defined parameters lasting ≥2
      hours, dose escalation in that participant will be halted and the participant may be
      withdrawn from the study or re-challenged at same dose or at a lower or divided dose.
      Participants that meet criteria listed will be followed up until parameters no longer meet
      stopping rule criteria.

      During the study, participants in Panel A were planned to receive placebo, 1 mg, 6 mg, 24 mg,
      72 mg and 108 mg, all in a fasted state in 5 periods. Participants in Panel B were planned to
      receive placebo, 3 mg, 12 mg, 48 mg, 72 mg and 162 mg, all in a fasted state in 5 periods.
      All periods in Panels A and B were conducted. Participants in Panel C were planned to receive
      placebo fasted, placebo fed, 120 mg fasted, 240 mg fasted, 360 mg fasted, 540 mg fasted, and
      120 mg fed in 5 periods. Periods 4 and 5 were not conducted and, as a result, the 240 mg
      fasted, 360 mg fasted, 540 mg fasted, 120 mg fed, and placebo fed doses were not
      administered. A 180 mg fasted dose was added during Period 3.
    

Intervention name(s): MK-7252; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 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; Placebo powder for oral suspension administered with a water volume that brings the total ingested volume to approximately 240 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment