Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01963260
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01963260
Study Brief:
Protocol Section:
NCT01963260