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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01963260
First received: October 11, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Immune Thrombocytopenia Purpura
Drug: MK-8723
Drug: Matching Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Part, Single Rising Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MK-8723 in Healthy Adults and Patients With Immune Thrombocytopenia Purpura

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 84 days ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Due to An AE [ Time Frame: Up to 84 Days ] [ Designated as safety issue: Yes ]
  • Participant Platelet Response Rate to MK-8723 [ Time Frame: Up to Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve (AUC[0-∞]) of MK-8723 Among Healthy Participants and Participants With ITP [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
  • Maximum Serum Concentration (Cmax) of MK-8723 Among Healthy Participants and Participants With ITP [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: October 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A: MK-8723 Very Low Dose in Healthy Participants
MK-8723 very low dose administered as a single intravenous (IV) infusion to healthy participants.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Experimental: Panel B: MK-8723 Low Dose in Healthy Participants
MK-8723 low dose administered as a single IV infusion to healthy participants.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Experimental: Panel C: MK-8723 Medium Dose in Healthy Participants
MK-8723 medium dose administered as a single IV infusion to healthy participants.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Experimental: Panel D: MK-8723 Medium-High Dose in Healthy Participants
MK-8723 medium-high dose administered as a single IV infusion to healthy participants.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Experimental: Panel E: MK-8723 High Dose in Healthy Participants
MK-8723 high dose administered as a single IV infusion to healthy participants.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Experimental: Panel F: MK-8723 Medium Dose in ITP Participants
MK-8723 medium dose administered as a single IV infusion to participants with ITP.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Experimental: Panel G: MK-8723 Medium-High Dose in ITP Participants
MK-8723 medium-high dose administered as a single IV infusion to participants with ITP.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Experimental: Panel H: MK-8723 High Dose in ITP Participants
MK-8723 high dose administered as a single IV infusion to participants with ITP.
Drug: MK-8723
MK-8723 administered as a single IV infusion.
Placebo Comparator: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1 of Study Part 1 and Study Part 2 in Panels A, B, C, D, E, F, G, H.
Drug: Matching Placebo
Matching placebo to MK-8723 administered as a single IV infusion.

Detailed Description:

In Part 1 of the trial, safety and pharmacokinetics of MK-8723 will be evaluated in healthy participants. In Part 2 of the trial, safety, pharmacokinetics, and pharmacodynamics will be evaluated among participants with ITP. In Part 1, dose escalation will occur in up to 5 serial panels of partcipants (Panels A, B, C, D, and E); each participant will receive a single intravenous (IV) dose of MK-8723 (or placebo). In Part 2, dose escalation will occur in up to 3 serial panels of participants with ITP (Panels F, G and H); each participant will receive a single IV dose of MK-8723 (or placebo), once safety and tolerability of the corresponding dose is shown in Part 1.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 (HGC) 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 o f blood within 4 weeks;
  • Has participated in another investigational trial within 4 weeks (12 weeks for biologics);
  • Has a history of ITP unresponsive to intravenous immunoglobulin (IVIG);
  • Has had systemic corticosteroid use within 1month (with the exception of stable low dose oral corticosteroids);
  • Has had systemic IVIG or other systemic immunomodulatory therapy 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963260

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Gary Jankelowitz    61 2 8988 8246      
Israel
Merck Sharp & Dohme Co. Ltd. Recruiting
Hod Hasharon, Israel
Contact: Ofer Sharon    972 9 9539310      
Moldova, Republic of
Merck Sharp & Dohme IDEA, Inc. Recruiting
Chisinau, Moldova, Republic of
Contact: Tatyana Gots    38 044 393-7480      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01963260     History of Changes
Other Study ID Numbers: 8723-001
Study First Received: October 11, 2013
Last Updated: August 14, 2014
Health Authority: Australia: National Health and Medical Research Council
Israel: Ministry of Health

Additional relevant MeSH terms:
Purpura
Thrombocytopenia
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Blood Platelet Disorders
Thrombotic Microangiopathies
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014