Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)
Condition: Immune Thrombocytopenia Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Intervention: MK-8723; Matching Placebo
Intervention description: MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.; Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objectives of this study are to assess the safety and tolerability of single
      rising doses of MK-8723 in healthy adult participants and adult participants with chronic
      immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in
      participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet
      response rate to MK-8723 in adult patients with chronic ITP is >50%.
    

Eligibility criteria:

        Inclusion Criteria (Part 1):

          -  Female participants must be non-pregnant, non-breast feeding, and of non-childbearing
             potential

          -  Has a Body Mass Index (BMI) <=32 kg/m^2

          -  Has a body weight >= 50 kg and <= 100 kg

          -  Has been judged to be in good health based on medical history, physical examination,
             vital sign measurements, electrocardiogram (ECG), and laboratory safety tests

          -  Non-smoker or has not used nicotine or nicotine-containing products for at least 3
             months

        Inclusion Criteria (Part 2):

          -  Has been diagnosed with ITP at least 3 months prior

          -  Female ITP participants must be non-pregnant, non-breast feeding, and either of 1)
             non-childbearing potential or 2) must have serum beta human chorionic gonadotropin
             (HCG) level consistent with a non-pregnant state, and agree to use acceptable
             contraception from pretrial period until 84 days postdose

          -  Has a BMI <=36 kg/m^2

          -  Has been judged to be in good health, other than ITP diagnosis, based on medical
             history, physical examination, vital sign measurements, ECG, and laboratory safety
             tests

        Exclusion Criteria (Part 1):

          -  Has a history or clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary, or major
             neurological abnormalities or diseases

          -  Has a history of cancer (malignancy)

          -  Has a history of significant multiple and/or severe allergies or has had an
             anaphylactic reaction or significant intolerability to prescription or
             non-prescription drugs or food

          -  Is positive for hepatitis B surface antigen, hepatitis C antibodies, or human
             immunodeficiency virus (HIV)

          -  Has had major surgery or donated or lost 1 unit of blood in the 4 weeks prior

          -  Has participated in another investigational trial within 4 weeks (12 weeks for
             biologics)

          -  Has received a live virus vaccination within 42 days or plans to receive such while
             participating in the trial

          -  Is unable to refrain from or anticipates the use of any medication, including
             prescription and non-prescription drugs and herbal remedies from 2 weeks prior and for
             the duration of the trial

          -  Consumes greater than 3 glasses of alcoholic beverages per day

          -  Consumes greater than 6 servings of caffeine-containing beverages per day

          -  Is currently a regular user of any illicit drugs or has a history of drug and/or
             alcohol abuse within 3 months

          -  Has a history of ITP or other autoimmune disease

          -  Has an active infection that is clinically significant

        Exclusion Criteria (Part 2):

          -  Has a comorbid and significant hematological or immunological disorder

          -  Has a history of significant multiple and/or severe allergies or has had an
             anaphylactic reaction or significant intolerability to prescription or
             non-prescription drugs or food

          -  Is positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV

          -  Has had major surgery or donated or lost 1 unit of blood within 4 weeks

          -  Has participated in another investigational trial within 4 weeks (12 weeks for
             biologics), excluding prior participation in the current study

          -  Has a history of ITP unresponsive to intravenous immunoglobulin (IVIG)

          -  Has had systemic corticosteroid use within 1 month (with the exception of stable low
             dose oral corticosteroids)

          -  Has had systemic IVIG or other systemic immunomodulatory therapy, excluding MK-8723
             administration in the current study, within 3 months

          -  Has received a thrombopoietin receptor antagonist within 3 months

          -  Is unable to refrain from using thrombopoietin receptor agonists and/or systemic
             immune modulatory medications throughout the study

          -  Has received a live virus vaccine within 42 days prior or plans to receive such during
             the trial

          -  Consumes greater than 3 alcoholic beverages per day

          -  Consumes greater than 6 servings of caffeine-containing beverages per day

          -  Is currently a regular user of any illicit drugs or has a history of drug and/or
             alcohol abuse within 3 months

          -  Has clinical evidence of bleeding or coagulopathy including petechial rash, easy
             bruising, or excessive gingival bleeding with routine dental hygiene

          -  Has an active infection that is clinically significant