Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)

• Status: Completed
• Trial end date: 2015-04-26
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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