Trial · NCT03230916
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
NCT03230916, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2021-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020). Trials, record NCT03230916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03230916
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
- NCT number
- NCT03230916
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 47 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Suspected or Documented Gram-negative Bacterial Infection
- Interventions
- IMI/REL FDC
- First posted
- 2017-07-27
- Last updated
- 2024-02-06
- Other registries' IDs
- eudract:2016-004328-43
- Results first posted
- 2021-12-13
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma imipenem (IMI) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. |
| Primary | IMI Maximum Concentration (Cmax) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Maximum plasma concentration (Cmax) of IMI was calculated. Cmax is the peak plasma concentration of study drug after administration. |
| Primary | IMI Central Volume of Distribution (Vc) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Central volume of distribution (Vc) of plasma IMI was calculated. |
| Primary | IMI Clearance (CL) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Systemic clearance (CL) of plasma IMI was calculated. |
| Primary | IMI Percentage of Time Above the Minimum Concentration (%TMIC) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Percentage of time spent above the minimum inhibitory concentration (%TMIC) of plasma IMI was calculated. %TMIC is defined as the percentage of time (in hours) in which the lowest concentration of a study drug, completely inhibits growth of the specific organism being tested. |
| Primary | Relebactam (REL) AUC0-∞ | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma relebactam (REL) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. |
| Primary | REL Maximum Concentration (Cmax) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Maximum plasma concentration (Cmax) of REL was calculated. Cmax is the peak plasma concentration of study drug after administration. |
| Primary | REL Clearance (CL) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Systemic clearance (CL) of plasma REL was calculated. |
| Primary | REL Central Volume of Distribution (Vc) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Central volume of distribution (Vc) of plasma REL was calculated. |
| Primary | Cilastatin (CIL) AUC0-∞ | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma cilastatin (CIL) was not calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI AUC0-∞ | μM*hr | GEOMETRIC_MEAN |
| PRIMARY | IMI Maximum Concentration (Cmax) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI Cmax | μM | GEOMETRIC_MEAN |
| PRIMARY | IMI Central Volume of Distribution (Vc) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI Vc | Liters | GEOMETRIC_MEAN |
| PRIMARY | IMI Clearance (CL) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI CL | L/hr | GEOMETRIC_MEAN |
| PRIMARY | IMI Percentage of Time Above the Minimum Concentration (%TMIC) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI %TMIC | Percentage of time | GEOMETRIC_MEAN |
| PRIMARY | Relebactam (REL) AUC0-∞ | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL AUC0-∞ | μM*hr | GEOMETRIC_MEAN |
| PRIMARY | REL Maximum Concentration (Cmax) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Cmax | μM | GEOMETRIC_MEAN |
| PRIMARY | REL Clearance (CL) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL CL | L/hr | GEOMETRIC_MEAN |
| PRIMARY | REL Central Volume of Distribution (Vc) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Vc | Liters | GEOMETRIC_MEAN |
| PRIMARY | Cilastatin (CIL) AUC0-∞ | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Due to sparse PK sampling schedule, per participant data could not be calculated. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group143
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 1: IMI/REL 500/250 mg 30-minute Infusion | 134.7 | Geometric Coefficient of Variation 19.8 | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion | 153.2 | Geometric Coefficient of Variation NA | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion | 219.4 | Geometric Coefficient of Variation 39.2 | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 2: IMI/REL 500/250 mg 30-minute Infusion | 139.4 | Geometric Coefficient of Variation 26.6 | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 2: IMI/REL 500/250 mg 60-minute Infusion | 140 | Geometric Coefficient of Variation NA | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion | 156 | Geometric Coefficient of Variation 18.9 | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion | 163 | Geometric Coefficient of Variation 31.2 | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion | 95.4 | Geometric Coefficient of Variation 39.3 | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion | 219.2 | Geometric Coefficient of Variation 39.6 | μM*hr | |
| Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion | 152.5 | Geometric Coefficient of Variation 14.1 | μM*hr |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: IMI/REL 15/7.5 mg/kg | 7 | |
| Overall Study | STARTED | Cohort 2: IMI/REL 15/7.5 mg/kg | 6 | |
| Overall Study | STARTED | Cohort 3: IMI/REL 15/7.5 mg/kg | 6 | |
| Overall Study | STARTED | Cohort 4: IMI/REL 10/5 mg/kg | 4 | |
| Overall Study | STARTED | Cohort 4: IMI/REL 15/7.5 mg/kg | 4 | |
| Overall Study | STARTED | Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg | 6 | |
| Overall Study | STARTED | Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg | 3 | |
| Overall Study | STARTED | Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg | 2 | |
| Overall Study | STARTED | Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg | 2 | |
| Overall Study | STARTED | Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg | 3 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: IMI/REL 15/7.5 mg/kg | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: IMI/REL 15/7.5 mg/kg | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3: IMI/REL 15/7.5 mg/kg | 2 | 6 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 4: IMI/REL 10/5 mg/kg | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 4: IMI/REL 15/7.5 mg/kg | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg | 0 | 3 | 0 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: IMI/REL 15/7.5 mg/kg | 0 | 7 |
| Total, all-cause mortality | Cohort 2: IMI/REL 15/7.5 mg/kg | 0 | 6 |
| Total, all-cause mortality | Cohort 3: IMI/REL 15/7.5 mg/kg | 0 | 6 |
| Total, all-cause mortality | Cohort 4: IMI/REL 10/5 mg/kg | 0 | 4 |
| Total, all-cause mortality | Cohort 4: IMI/REL 15/7.5 mg/kg | 0 | 4 |
| Total, all-cause mortality | Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg | 0 | 5 |
| Total, all-cause mortality | Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg | 0 | 3 |
| Total, all-cause mortality | Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg | 0 | 2 |
| Total, all-cause mortality | Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg | 0 | 2 |
| Total, all-cause mortality | Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg | 0 | 3 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37562063 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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