HypersensitivityPhase 1NCT00988065

Sugammadex Hypersensitivity Study (Study P06042)

A Phase 1 study testing Sugammadex 4 mg/kg and Sugammadex 16 mg/kg in people with Hypersensitivity, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hypersensitivity
What is being tested?: Sugammadex 4 mg/kg and Sugammadex 16 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 448 participants
Where: No sites listed yet
Study dates: 6 Sep 2009to 13 Apr 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18-55 years of age
Serum tryptase <=11.4 mcg/L and fasting triglyceride levels within normal limits
Safety laboratory tests and vital signs must have been within normal limits
Screening electrocardiogram must have been clinically acceptable and parameters within normal limits
Body Mass Index between 19 and 32 kg/m^2
Females must have agreed to use contraceptives
Other certain administrative criteria as described in the protocol

Who cannot join

Females who were pregnant or intending to become pregnant
Subjects who would not be able to participate optimally in the study, in the opinion of the investigator
Certain surgical or medical conditions, recent infections, or mental instability
Positive test for certain drugs or history of alcohol or drug abuse
Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
Blood donation in the past 60 days

Show all 12Show fewer

A history of unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia
History of anaphylaxis from any cause, suspected history of hypersensitivity to cyclodextrins, or multiple drug hypersensitivities
Heavy smoker
Received certain medications in the past
History of allergy, hypersensitivity, or intolerance to epinephrine at greater risk of developing adverse reactions after epinephrine administration
Other certain administrative criteria as described in the protocol

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Incidence of Hypersensitivity After Repeated Single Dose Administrations of Sugammadex (SCH 900616) in Healthy Subjects

In total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.

Read the detailed description

All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. Four sites participated in this trial.

Conditions: Hypersensitivity
Being tested: Placebo run-in dose, Sugammadex 4 mg/kg, Sugammadex 16 mg/kg, Placebo
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo run-in doseDrug
Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization
Sugammadex 4 mg/kgDrug
Also called SCH 900616, Org 25969, Bridion®
Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
Sugammadex 16 mg/kgDrug
Also called SCH 900616, Org 25969, Bridion®
Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
PlaceboDrug
Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study

Study groups in NCT00988065
Study group	Role	What they receive
Sugammadex 4 mg/kg	Experimental	Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study. Receives: Drug: Placebo run-in dose; Drug: Sugammadex 4 mg/kg
Sugammadex 16 mg/kg	Experimental	Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study. Receives: Drug: Placebo run-in dose; Drug: Sugammadex 16 mg/kg
Placebo	Placebo comparator	Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study. Receives: Drug: Placebo run-in dose; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.
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.
Measured: Day 8, Day 36, and Day 78 of the study

Secondary outcomes (3)

The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.
The Adjudication Committee evaluated each case to determine whether the subject's hypersensitivity sign/symptoms fulfilled the definition of anaphylaxis according to the criteria defined by the Symposium on the Definition and Management of Anaphylaxis as described by Sampson et al. (J Allergy Clin Immunol 2006; 117:391-7).
The percentages of subjects who had adjudicated anaphylaxis according to the Sampson Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups.
Measured: Day 8, Day 36, and Day 78 of the study
The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.
The Adjudication Committee evaluated each case to determine anaphylaxis according to the criteria put forth by the guidelines of the Brighton Collaboration Anaphylaxis Working Group as described by Rüggeberg et al. (Vaccine 2007; 25:5675-5684).
Level 1 represents the highest level of certainty of anaphylaxis and level 3 the lowest level of certainty.
The percentages of subjects who had adjudicated anaphylaxis according to the Rüggeberg Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups.
Measured: Day 8, Day 36, and Day 78 of the study
The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.
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 \& 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 (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) are presented for each of the 3 treatment arms for each dose.
Measured: Day 8, Day 36, and Day 78 of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 200913 Apr 2010

First posted1 Oct 2009 (estimated)
Study start6 Sep 2009
Primary completion13 Apr 2010
Study completion13 Apr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypersensitivityStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 448 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00988065
Sponsor's protocol ID: P06042
Other IDs: EUDRACT: 2009-012014-40
Status last verified: Jan 2019
First submitted: 30 Sep 2009
Last updated: 30 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

de Kam PJ, Nolte H, Good S, Yunan M, Williams-Herman DE, Burggraaf J, Kluft C, Adkinson NF, Cullen C, Skov PS, Levy JH, van den Dobbelsteen DJ, van Heumen ELGM, van Meel FCM, Glassner D, Woo T, Min KC, Peeters PAM. Sugammadex hypersensitivity and underlying mechanisms: a randomised study of healthy non-anaesthetised volunteers. Br J Anaesth. 2018 Oct;121(4):758-767. doi: 10.1016/j.bja.2018.05.057. Epub 2018 Jul 13.
PubMed 30236238

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Recruiting
BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Asthma
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
Active, not recruitingPhase 2
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
SSM, Mastocytosis, Indolent

All Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Incidence of Hypersensitivity After Repeated Single Dose Administrations of Sugammadex (SCH 900616) in Healthy Subjects
ClinicalTrials.gov ID: NCT00988065
Acronym / sponsor ID: P06042
Conditions: Hypersensitivity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 448 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Sep 2009 (actual)
Primary completion: 13 Apr 2010 (actual)
Study completion: 13 Apr 2010 (actual)
First posted: 1 Oct 2009 (estimated)
Results: Posted 11 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Sugammadex 4 mg/kg	Experimental	Drug: Placebo run-in dose, Drug: Sugammadex 4 mg/kgParticipants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Sugammadex 16 mg/kg	Experimental	Drug: Placebo run-in dose, Drug: Sugammadex 16 mg/kgParticipants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Placebo	Placebo comparator	Drug: Placebo run-in dose, Drug: PlaceboParticipants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

18-55 years of age
Serum tryptase <=11.4 mcg/L and fasting triglyceride levels within normal limits
Safety laboratory tests and vital signs must have been within normal limits
Screening electrocardiogram must have been clinically acceptable and parameters within normal limits
Body Mass Index between 19 and 32 kg/m^2

Key exclusion criteria (12 listed)

Females who were pregnant or intending to become pregnant
Subjects who would not be able to participate optimally in the study, in the opinion of the investigator
Certain surgical or medical conditions, recent infections, or mental instability
Positive test for certain drugs or history of alcohol or drug abuse
Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo run-in doseSingle-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization	Drug	Placebo, Sugammadex 16 mg/kg, Sugammadex 4 mg/kg
Sugammadex 4 mg/kgAlso: SCH 900616, Org 25969, Bridion®Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study	Drug	Sugammadex 4 mg/kg
Sugammadex 16 mg/kgAlso: SCH 900616, Org 25969, Bridion®Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study	Drug	Sugammadex 16 mg/kg
PlaceboPlacebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study	Drug	Placebo

Primary outcome

The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.
Time frame: Day 8, Day 36, and Day 78 of the study
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.

3 secondary outcomes

The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.
Time frame: Day 8, Day 36, and Day 78 of the study
The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.
Time frame: Day 8, Day 36, and Day 78 of the study
The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.
Time frame: Day 8, Day 36, and Day 78 of the study

Results and safety

Results posted to the registry on 11 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sugammadex 4 mg/kg	148	135
Sugammadex 16 mg/kg	150	127
Placebo	150	135

Primary outcome: The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.

Time frame: Day 8, Day 36, and Day 78 of the study. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Sugammadex 4 mg/kg n = 148	Sugammadex 16 mg/kg n = 150	Placebo n = 150
Value	0.7 (0.0 to 3.7)	4.7 (1.9 to 9.4)	0 (0 to 2.4)

Sugammadex 4 mg/kg vs Placebo: Difference in event rates: 0.7 (95% CI -1.8 to 3.7)
Sugammadex 16 mg/kg vs Placebo: Difference in event rates: 4.7 (95% CI 2.1 to 9.3)

Population analysed: All-Subjects as treated (i.e., who received at least one dose of randomized study medication).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) that started after first dose of randomized study medication up to 30 days after day of last dose of randomized study medication, i.e. the "Treatment-emergent" AEs.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sugammadex 4 mg/kg	0 of 148 (0%)	35 of 148 (23.6%)	Not reported
Sugammadex 16 mg/kg	2 of 150 (1.3%)	64 of 150 (42.7%)	Not reported
Placebo	1 of 150 (0.7%)	33 of 150 (22%)	Not reported

Limitations and caveats (from the sponsor): Results from this study in healthy/conscious subjects may not be fully applicable to anesthetized patient settings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30236238de Kam PJ, Nolte H, Good S, Yunan M, Williams-Herman DE, Burggraaf J, Kluft C, Adkinson NF, Cullen C, Skov PS, Levy JH, van den Dobbelsteen DJ, van Heumen ELGM, van Meel FCM, Glassner D, Woo T, Min KC, Peeters PAM. Sugammadex hypersensitivity and underlying mechanisms: a randomised study of healthy non-anaesthetised volunteers. Br J Anaesth. 2018 Oct;121(4):758-767. doi: 10.1016/j.bja.2018.05.057. Epub 2018 Jul 13.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Hypersensitivity

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Recruiting
BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Asthma
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
Active, not recruitingPhase 2
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
SSM, Mastocytosis, Indolent

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sugammadex 4 mg/kg and Sugammadex 16 mg/kg in people with Hypersensitivity, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo. (time frame: Day 8, Day 36, and Day 78 of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019; AzTrials last refreshed its copy on 27 Oct 2026.