Healthy VolunteersPhase 1NCT05395104

A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

A Phase 1 study testing Midazolam and Cefiderocol in people with Healthy Volunteers, run by Shionogi at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Midazolam and Cefiderocol
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 24 May 2022to 13 Jul 2022
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiography at the Screening Visit and upon admission to the clinical research unit (CRU).
Body weight ≥ 50 kilograms (kg) and body mass index within the range of ≥ 18.5 to ≤ 32.0 kg/meter squared at the Screening Visit.

Who cannot join

History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
Systolic blood pressure outside the range of 90 to 145 millimeters of mercury (mmHg), diastolic blood pressure outside the range of 50 to 95 mmHg, pulse rate outside the range of 40 to 100 beats per minute, or blood pressure or pulse values considered clinically significant by the investigator at the Screening Visit or upon admission to the CRU. Abnormal values may be retested once.
Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Breast cancer within the past 10 years.
Past use of over-the-counter or prescription medication, including herbal medications, traditional Chinese medicines, vitamins, minerals, dietary supplements, and vaccines within 14 days (or 5 terminal half-lives, whichever is longer) prior to admission to the CRU (which will occur on Day -2) or intended use of any of the above throughout the study enrollment.
Significant blood loss of ≥ 500 milliliters or blood or plasma donation within 56 days prior to the Screening Visit until completion of the study, or from the Screening Period until admission to the CRU through completion of the study.

Show all 10Show fewer

History of coronavirus disease 2019 (COVID-19) infection within 14 days prior to the Screening Visit or admission, or close contact with a COVID-19 patient in the days prior to the Screening Visit or admission as reported by the participant and the participant's medical history.
History of drug or alcohol abuse/addiction.
Regularly consumes excessive amounts of caffeine, defined as > 6 servings of coffee, tea, caffeinated soft drinks, or other caffeinated beverages per day (1 serving is approximately equivalent to 120 milligrams of caffeine).
Used tobacco- or nicotine-containing products (including cigarette, pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum) within 6 months prior to admission to the CRU or refuses to refrain from using tobacco- or nicotine-containing products throughout the study (including Follow-up Period).

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trials
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A Phase 1, Open-label, 1-sequence Crossover, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Cefiderocol on the Pharmacokinetics of Midazolam in Healthy Adult Participants

The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.

Conditions: Healthy Volunteers
Being tested: Midazolam, Cefiderocol

What participants receive

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

MidazolamDrug
Syrup for oral administration
CefiderocolDrug
Liquid for intravenous infusion

Study groups in NCT05395104
Study group	Role	What they receive
Cefiderocol Plus Midazolam	Experimental	A total of 2 doses of midazolam and 45 doses of cefiderocol was administered to each participant per specified dosing schedule. Receives: Drug: Midazolam; Drug: Cefiderocol

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Cmax is reported as nanograms/milliliter (ng/mL). Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Time to Maximum Plasma Concentration (Tmax) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Tmax is reported in hours (hrs). Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. AUC0-last was calculated using the linear up/log down trapezoidal method and is reported as nanograms times hours/milliliter (ng*hrs/mL). Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Area Under the Concentration-time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. AUC0-inf was calculated as: AUC0-last + [Clast/λz], where Clast is the last measured concentration and λz is the plasma terminal elimination rate constant on Days -1 and 15. Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Terminal Elimination Half-life (t1/2,z) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. t1/2,z was calculated as: (ln2)/λz on Days -1 and 15. Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Terminal Elimination Rate Constant (λz) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. λz is the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase on Days -1 and 15 and is reported as 1/hours (1/h). Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Mean Residence Time (MRT) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. MRT was calculated as: AUMC0-inf/AUC0-inf, and AUMC0-inf is the area under the first moment curve extrapolated to infinity on Days -1 and 15. Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Apparent Total Clearance (CL/F) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. CL/F was calculated as: Dose/AUC0-inf on Days -1 and 15 and is reported as liters/hr. Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
Apparent Volume of Distribution (Vz/F) of Midazolam
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Vz/F was calculated as: Dose/AUC0-inf/λz on Days -1 and 15 and is reported as liters. Day -1 is defined as Baseline.
Measured: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15

Secondary outcomes (4)

Cmax of Cefiderocol
This outcome measure presents the pharmacokinetics of cefiderocol when coadministered with midazolam. Cmax is reported as micrograms/milliliter (μg/mL).
Measured: Day 15
Tmax of Cefiderocol
This outcome measure presents the pharmacokinetics of cefiderocol when coadministered with midazolam.
Measured: Day 15
Area Under the Plasma Concentration-time Curve Over the Dosing Interval τ (8 Hours) (AUC0-τ) of Cefiderocol
This outcome measure presents the pharmacokinetics of cefiderocol when coadministered with midazolam. AUC0-τ was calculated by the linear up/log down trapezoidal method and is reported as micrograms times hours/milliliter (μg*hrs/mL).
Measured: Day 15
CL of Cefiderocol
This outcome measure presents the PK of cefiderocol when coadministered with midazolam. CL was calculated as: Dose/AUC0-τ on Day 15.
Measured: Day 15

Timeline

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

24 May 202213 Jul 2022

First posted27 May 2022
Study start24 May 2022
Primary completion13 Jul 2022
Study completion13 Jul 2022

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.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by ShionogiThe 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: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05395104
Sponsor's protocol ID: 2136R2118
Status last verified: Mar 2023
First submitted: 23 May 2022
Last updated: 14 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, 1-sequence Crossover, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Cefiderocol on the Pharmacokinetics of Midazolam in Healthy Adult Participants
ClinicalTrials.gov ID: NCT05395104
Acronym / sponsor ID: 2136R2118
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 24 May 2022 (actual)
Primary completion: 13 Jul 2022 (actual)
Study completion: 13 Jul 2022 (actual)
First posted: 27 May 2022 (actual)
Results: Posted 14 Dec 2023

Clinical summary

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

The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cefiderocol Plus Midazolam	Experimental	Drug: Midazolam, Drug: CefiderocolA total of 2 doses of midazolam and 45 doses of cefiderocol was administered to each participant per specified dosing schedule.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiography at the Screening Visit and upon admission to the clinical research unit (CRU).
Body weight ≥ 50 kilograms (kg) and body mass index within the range of ≥ 18.5 to ≤ 32.0 kg/meter squared at the Screening Visit.

Key exclusion criteria (10 listed)

History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
Systolic blood pressure outside the range of 90 to 145 millimeters of mercury (mmHg), diastolic blood pressure outside the range of 50 to 95 mmHg, pulse rate outside the range of 40 to 100 beats per minute, or blood pressure or pulse values considered clinically significant by the investigator at the Screening Visit or upon admission to the CRU. Abnormal values may be retested once.
Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Breast cancer within the past 10 years.
Past use of over-the-counter or prescription medication, including herbal medications, traditional Chinese medicines, vitamins, minerals, dietary supplements, and vaccines within 14 days (or 5 terminal half-lives, whichever is longer) prior to admission to the CRU (which will occur on Day -2) or intended use of any of the above throughout the study enrollment.

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
MidazolamSyrup for oral administration	Drug	Cefiderocol Plus Midazolam
CefiderocolLiquid for intravenous infusion	Drug	Cefiderocol Plus Midazolam

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Cmax is reported as nanograms/milliliter (ng/mL). Day -1 is defined as Baseline.
Time to Maximum Plasma Concentration (Tmax) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Tmax is reported in hours (hrs). Day -1 is defined as Baseline.
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. AUC0-last was calculated using the linear up/log down trapezoidal method and is reported as nanograms times hours/milliliter (ng*hrs/mL). Day -1 is defined as Baseline.
Area Under the Concentration-time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. AUC0-inf was calculated as: AUC0-last + [Clast/λz], where Clast is the last measured concentration and λz is the plasma terminal elimination rate constant on Days -1 and 15. Day -1 is defined as Baseline.
Terminal Elimination Half-life (t1/2,z) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. t1/2,z was calculated as: (ln2)/λz on Days -1 and 15. Day -1 is defined as Baseline.
Terminal Elimination Rate Constant (λz) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. λz is the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase on Days -1 and 15 and is reported as 1/hours (1/h). Day -1 is defined as Baseline.
Mean Residence Time (MRT) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. MRT was calculated as: AUMC0-inf/AUC0-inf, and AUMC0-inf is the area under the first moment curve extrapolated to infinity on Days -1 and 15. Day -1 is defined as Baseline.
Apparent Total Clearance (CL/F) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. CL/F was calculated as: Dose/AUC0-inf on Days -1 and 15 and is reported as liters/hr. Day -1 is defined as Baseline.
Apparent Volume of Distribution (Vz/F) of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15
This outcome measure presents the effects of repeated doses of cefiderocol on the pharmacokinetics of midazolam. Vz/F was calculated as: Dose/AUC0-inf/λz on Days -1 and 15 and is reported as liters. Day -1 is defined as Baseline.

4 secondary outcomes

Cmax of Cefiderocol
Time frame: Day 15
Tmax of Cefiderocol
Time frame: Day 15
Area Under the Plasma Concentration-time Curve Over the Dosing Interval τ (8 Hours) (AUC0-τ) of Cefiderocol
Time frame: Day 15
CL of Cefiderocol
Time frame: Day 15

Results and safety

Results posted to the registry on 14 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cefiderocol Plus Midazolam	14	12

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Midazolam

Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Cefiderocol Plus Midazolam n = 14
Midazolam Alone	25.3 (45.3)
Midazolam + Cefiderocol	28.8 (35.0)

Cefiderocol Plus Midazolam: Ratio: 1.0865 (90% CI 0.9724 to 1.2141)

Population analysed: Pharmacokinetics Parameter Population: All participants with at least 1 pharmacokinetics parameter estimated appropriately. Participants in the "Midazolam + Cefiderocol" population with available data were analyzed.

Primary outcome: Time to Maximum Plasma Concentration (Tmax) of Midazolam

Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15. Median (Full Range). Unit: hrs

Measure	Cefiderocol Plus Midazolam n = 14
Midazolam Alone	0.51 (0.50 to 1.00)
Midazolam + Cefiderocol	0.51 (0.50 to 1.07)

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Midazolam

Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hrs/mL

Measure	Cefiderocol Plus Midazolam n = 14
Midazolam Alone	66.13 (46.3)
Midazolam + Cefiderocol	77.37 (44.2)

Cefiderocol Plus Midazolam: Ratio: 1.1174 (90% CI 0.9784 to 1.2762)

Primary outcome: Area Under the Concentration-time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) of Midazolam

Time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hrs/mL

Measure	Cefiderocol Plus Midazolam n = 14
Midazolam Alone	68.69 (47.8)
Midazolam + Cefiderocol	81.07 (45.6)

Cefiderocol Plus Midazolam: Ratio: 1.1239 (90% CI 0.9887 to 1.2776)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day -1 through Day 23. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cefiderocol Plus Midazolam	0 of 14 (0%)	11 of 14 (78.6%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Midazolam and Cefiderocol in people with Healthy Volunteers, run by Shionogi at 1 site in United States.

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 2 inclusion and 10 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 14 Dec 2023). 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?

Maximum Observed Plasma Concentration (Cmax) of Midazolam (time frame: 0 (predose) up to 24 hours postdose on Day -1 (Midazolam alone at Baseline) and Day 15). The study lists 9 primary outcomes in all. 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 NCT05395104.

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 14 Dec 2023.