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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02028065 | A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101) | PHASE1 | COMPLETED | 382 | — | — | Jan 3, 2014 | Jul 1, 2014 | Apr 3, 2019 | - | — |
| NCT00988065 | Sugammadex Hypersensitivity Study (Study P06042) | PHASE1 | COMPLETED | 448 | — | — | Sep 6, 2009 | Apr 13, 2010 | Jan 30, 2019 | - | — |
The investigator or designated clinician performed a targeted hypersensitivity assessment (THA) in each participant at 0.5, 4 and 24 hours after each dose for each dosing period. The THA could also be performed at other times if possible hypersensitivity signs were observed. The THA included elicitation of symptoms as well as examination of the participant, covering neurologic, pulmonary, cardiovascular, gastrointestinal and dermatologic domains. Each potential hypersensitivity case identified by the presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of hypersensitivity (yes/no). In addition, all adverse events (AEs) occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.
Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists \& allergists/immunologists) for blinded review and determination of adjudicated hypersensitivity \&/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject. The percentages of subjects who had adjudicated hypersensitivity at any dose (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) were compared between the 3 treatment groups.
| Arm | Type | Description |
|---|---|---|
| Sugammadex 4 mg/kg | EXPERIMENTAL | Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3 |
| Sugammadex 16 mg/kg | EXPERIMENTAL | Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3 |
| Placebo | PLACEBO_COMPARATOR | Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3 |
| Name | Type | Description |
|---|---|---|
| Sugammadex | DRUG | Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds |
| Placebo | DRUG | Placebo administered as a single IV bolus over 10 seconds |
| Placebo run-in dose | DRUG | Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization |
| Sugammadex 4 mg/kg | DRUG | Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study |
| Sugammadex 16 mg/kg | DRUG | Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study |
Inclusion Criteria: * Male or non-pregnant and non-breast feeding female * Females of childbearing potential must have a serum β-human chorionic gonadotropin (β-hCG) level consistent with non-pregnant state and agree to use (and/or have their partner use) two acceptable methods of birth control beg...