Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01963260 | Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001) | PHASE1 | COMPLETED | 50 | — | — | Oct 31, 2013 | Apr 26, 2015 | Mar 15, 2019 | - | — |
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| MK-8723 | DRUG | MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1. |
| Matching Placebo | DRUG | Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1. |
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 examinati...