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

NCT01963260 | Completed Phase 1 Results

• 1 other identifier: 8723-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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%.

Conditions

Immune Thrombocytopenia Purpura

Outcome Measures

Primary Outcomes (3)

• Number of Participants Experiencing an Adverse Event

  An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  Up to 84 days

• Number of Participants Discontinuing Study Due to an Adverse Event (AE)

  An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  Up to 84 Days

• Number of Participants With a Positive Platelet Response to MK-8723

  In participants with ITP, platelet response is a rapid, sensitive, and highly qualitative measure of response to anti-inflammatory therapy. A positive platelet response was defined as: 1) A doubling of platelet counts at the time point of maximum response (through Day 14) as compared to Day 0 AND an increase to an absolute level of ≥50,000/μL in participants with a baseline platelet count of \<50,000/μL, OR 2) A 50% increase in the platelet count at the time point of maximum response (through Day 14) as compared to Day 0 in participants with a baseline platelet count of ≥50,000/μL. The analysis was specified only for participants with ITP (Part 2) that received treatment with MK-8723 or matching placebo.

  Up to Day 14

Secondary Outcomes (2)

• Area Under the Concentration-time Curve of MK-8723 From Time 0 to Infinity (AUC0-∞) Among Healthy Participants and Participants With ITP

  All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84

• Maximum Concentration (Cmax) of MK-8723 Among Healthy Participants and Participants With ITP

  All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84

Study Arms (10)

Part 1: MK-8723 1 mg/kg in Healthy Participants

EXPERIMENTAL

MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.

Drug: MK-8723

Part 1: MK-8723 3 mg/kg in Healthy Participants

EXPERIMENTAL

MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.

Drug: MK-8723

Part 1: MK-8723 10 mg/kg in Healthy Participants

EXPERIMENTAL

MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.

Drug: MK-8723

Part 1: MK-8723 30 mg/kg in Healthy Participants

EXPERIMENTAL

MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.

Drug: MK-8723

Part 1: MK-8723 100 mg/kg in Healthy Participants

EXPERIMENTAL

MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.

Drug: MK-8723

Part 1: Matching Placebo to MK-8723

PLACEBO COMPARATOR

Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.

Drug: Matching Placebo

Part 2: MK-8723 10 mg/kg in ITP Participants

EXPERIMENTAL

MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2.

Drug: MK-8723

Part 2: MK-8723 30 mg/kg in ITP Participants

EXPERIMENTAL

MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.

Drug: MK-8723

Part 2: MK-8723 100 mg/kg in ITP Participants

PLACEBO COMPARATOR

MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2.

Drug: MK-8723

Part 2: Matching Placebo to MK-8723

PLACEBO COMPARATOR

Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.

Drug: Matching Placebo

Interventions

MK-8723 DRUG

MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.

Part 1: MK-8723 1 mg/kg in Healthy Participants; Part 1: MK-8723 10 mg/kg in Healthy Participants; Part 1: MK-8723 100 mg/kg in Healthy Participants; Part 1: MK-8723 3 mg/kg in Healthy Participants; Part 1: MK-8723 30 mg/kg in Healthy Participants; Part 2: MK-8723 10 mg/kg in ITP Participants; Part 2: MK-8723 100 mg/kg in ITP Participants; Part 2: MK-8723 30 mg/kg in ITP Participants

Matching Placebo DRUG

Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.

Part 1: Matching Placebo to MK-8723; Part 2: Matching Placebo to MK-8723

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 16, 2013
• Study Start: October 31, 2013
• Primary Completion: April 26, 2015
• Study Completion: April 26, 2015
• Last Updated: March 15, 2019
• Results First Posted: March 21, 2017

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share