Healthy VolunteersPhase 1NCT03376529

Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741

A Phase 1 study testing SPR741, Ceftazidime and Piperacillin/tazobactam in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United Kingdom.

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: SPR741, Ceftazidime and Piperacillin/tazobactam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Nov 2017to 20 Dec 2017
Phase: Phase 1
Are there results?: None posted in the registry

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

Healthy adult males and/or females (of non-childbearing potential), 18 to 55 years of age (inclusive) at the time of screening;
BMI ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive);
Medically healthy without clinically significant abnormalities at the screening visit or Day -1, including:
Physical examination, vital signs. Vital signs include temperature, heart rate, respiratory rate, and blood pressure;
Triplicate ECGs taken at least 1 minute apart with QTcF interval duration less than 450 msec obtained as an average from the triplicate screening and pre-dose Day 1 ECGs after at least 5 min in a semi-supine quiet rest;
Hemoglobin/hematocrit, white blood cell (WBC) count, and platelet count equal to or greater than the lower limit of normal range of the reference laboratory;

Show all 14Show fewer

Creatinine, BUN, ALT and AST equal to or less than the upper limit of normal for the reference laboratory; results of all other clinical chemistry and urine analytes without any clinically significant abnormality.
Discussion between the PI and the Medical Monitor (MM) is encouraged regarding the potential significance of any laboratory value that is outside of the normal range during the pre-dose period.
Be non-smokers (including tobacco, e-cigarettes or marijuana) for at least 1 month prior to participation in the study;
Willing and able to provide written informed consent;
Be willing and able to comply with all study assessments and adhere to the protocol schedule;
Have suitable venous access for drug administration and blood sampling;
If female, be of non-childbearing potential (e.g. post-menopausal as demonstrated by FSH or surgical sterilization i.e., tubal ligation or hysterectomy). Provision of documentation is not required for female sterilization, verbal confirmation is adequate;
If male, a willingness not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation). This criterion applies to males (and/or female partners) who are surgically sterile and must be followed from the time of first study drug administration until 90 days after the final administration of study drug.

Who cannot join

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
History of known or suspected Clostridium difficile infection;
History of seizure disorders;
Positive urine drug/alcohol testing at screening or check-in (Day -1);
Positive testing for HIV, HBsAg or HCV;
History of substance abuse or alcohol abuse (defined as those who consume more than 14 units of alcohol per week, and where this consumption is spread over less than 3 days, or those who regularly (weekly) consumed excessive amounts of alcohol (>8 units for men and >6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics) within the previous 5 years;

Show all 11Show fewer

Use of any prescription medication or any over-the-counter medication, herbal products, vitamins, diet aids or hormone supplements within 7 days prior to randomisation;
Documented hypersensitivity reaction or anaphylaxis to any medication;
Donation of blood or plasma within 30 days prior to randomisation, or loss of whole blood of more than 500 mL within 30 days prior to randomisation, or receipt of a blood transfusion within 1 year of study enrollment;
Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
Any other condition or prior therapy, which, in the opinion of the PI, would make the volunteer unsuitable for this study, including unable to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Simbec Research, Ltd.
Merthyr Tydfil, Mid Glamorgan, CF48 4DR

Other trials in United Kingdom

About this study

Official title: A Single-center, Multi-arm, Open-label, Randomized, 3-period, Crossover, Phase 1 Study to Evaluate the DDI, PK, Safety, and Tolerability of Single Doses of SPR741 Co-administered With Three Different Antibiotics in Healthy Volunteers

This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3 different partner antibiotics, and the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate.

Read the detailed description

This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime, piperacillin/tazobactam, and aztreonam) in healthy volunteers. Participants will be administered a single dose of SPR741 alone, a single dose of SPR741 in combination with 1 of the 3 different partner antibiotics, and a single dose of the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase.

The 3 treatment arms will be enrolled and dosed in parallel or in a staggered manner, as needed for scheduling.

All participants in the study will be monitored for safety after administration of the last dose of investigational product.

Conditions: Healthy Volunteers
Being tested: SPR741, Ceftazidime, Piperacillin/tazobactam, Aztreonam
Keywords: safety, tolerability, pharmacokinetics, drug-drug interaction, SPR741, antibiotic

What participants receive

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

SPR741Drug
400 mg IV over 1 hour
CeftazidimeDrug
1.0 gram IV over 1 hour
Piperacillin/tazobactamDrug
4.5 grams IV over 1 hour
AztreonamDrug
1.0 gram IV over 1 hour

Study groups in NCT03376529
Study group	Role	What they receive
SPR741/Ceftazidime (N=9)	Experimental	Nine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + ceftazidime1.0 gram IV over 1 hour, and ceftazidime 1.0 gram IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm. Receives: Drug: SPR741; Drug: Ceftazidime
SPR741/Piperacillin/tazobactam (N=9)	Experimental	Nine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + piperacillin/tazobactam 4.5 grams IV over 1 hour, and piperacillin/tazobactam 4.5 grams IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm. Receives: Drug: SPR741; Drug: Piperacillin/tazobactam
SPR741/Aztreonam (N=9)	Experimental	Nine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + aztreonam 1.0 gram IV over 1 hour, and aztreonam 1.0 gram IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm. Receives: Drug: SPR741; Drug: Aztreonam

What is being measured

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

Pharmacokinetics: Maximum concentration (Cmax)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8
Pharmacokinetics: Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8
Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8
Pharmacokinetics: Time to maximum concentration (Tmax)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8
Pharmacokinetics: Terminal Elimination Rate Constant (kel)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8
Pharmacokinetics: Terminal half-life (t1/2)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8
Pharmacokinetics: Terminal clearance (CL)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8
Pharmacokinetics: Volume of distribution (Vd)
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Measured: Days 1 to 2, Days 4 to 5, Days 7 to 8

Secondary outcomes (15)

Safety measures: adverse events (AEs)
The types and frequency of AEs
Measured: Day -1 to Day 9
Safety measures: Summary of type and frequency of concomitant medication
The type and frequency of medications used will be summarized
Measured: Day -1 to Day 9
Safety measures: change in temperature (C/F)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: change in blood pressure (mmHg)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: change in heart rate (beats per minute)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant physical exam findings
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (RR Interval)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (P wave)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (PR Interval)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (QRS)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (ST Segment)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (T Wave)
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures:abnormal, clinically significant changes in urinalysis from baseline to end of study
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant hematology changes from baseline to end of study
Change from baseline to end of study
Measured: Day -1 to Day 9
Safety measures: abnormal, clinically significant serum chemistry changes from baseline to end of study
Change from baseline to end of study
Measured: Day -1 to Day 9

Timeline

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

10 Nov 201720 Dec 2017

First posted18 Dec 2017
Study start10 Nov 2017
Primary completion19 Dec 2017
Study completion20 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
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: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03376529
Sponsor's protocol ID: SPR741-102
Status last verified: Jan 2018
First submitted: 5 Dec 2017
Last updated: 5 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Eckburg PB, Lister T, Walpole S, Keutzer T, Utley L, Tomayko J, Kopp E, Farinola N, Coleman S. Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741, an Intravenous Potentiator, after Single and Multiple Ascending Doses and When Combined with beta-Lactam Antibiotics in Healthy Subjects. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00892-19. doi: 10.1128/AAC.00892-19. Print 2019 Sep.
PubMed 31262767

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 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Multi-arm, Open-label, Randomized, 3-period, Crossover, Phase 1 Study to Evaluate the DDI, PK, Safety, and Tolerability of Single Doses of SPR741 Co-administered With Three Different Antibiotics in Healthy Volunteers
ClinicalTrials.gov ID: NCT03376529
Acronym / sponsor ID: SPR741-102
Conditions: Healthy Volunteers
Keywords: safety, tolerability, pharmacokinetics, drug-drug interaction, SPR741, antibiotic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Spero TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Simbec Research, QPS Holdings LLC
Study start: 10 Nov 2017 (actual)
Primary completion: 19 Dec 2017 (actual)
Study completion: 20 Dec 2017 (actual)
First posted: 18 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

The 3 treatment arms will be enrolled and dosed in parallel or in a staggered manner, as needed for scheduling.

All participants in the study will be monitored for safety after administration of the last dose of investigational product.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
SPR741/Ceftazidime (N=9)	Experimental	Drug: SPR741, Drug: CeftazidimeNine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + ceftazidime1.0 gram IV over 1 hour, and ceftazidime 1.0 gram IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm.
SPR741/Piperacillin/tazobactam (N=9)	Experimental	Drug: SPR741, Drug: Piperacillin/tazobactamNine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + piperacillin/tazobactam 4.5 grams IV over 1 hour, and piperacillin/tazobactam 4.5 grams IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm.
SPR741/Aztreonam (N=9)	Experimental	Drug: SPR741, Drug: AztreonamNine (9) participants will be enrolled and assigned to receive SPR741 400 mg IV over 1 hour, SPR741 400 mg IV over 1 hour + aztreonam 1.0 gram IV over 1 hour, and aztreonam 1.0 gram IV over 1 hour in a randomized sequence. One treatment will be administered during each of 3 dose periods within the assigned treatment arm.

Who may qualify

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

Key inclusion criteria (14 listed)

Healthy adult males and/or females (of non-childbearing potential), 18 to 55 years of age (inclusive) at the time of screening;
BMI ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive);
Medically healthy without clinically significant abnormalities at the screening visit or Day -1, including:
Discussion between the PI and the Medical Monitor (MM) is encouraged regarding the potential significance of any laboratory value that is outside of the normal range during the pre-dose period.
Be non-smokers (including tobacco, e-cigarettes or marijuana) for at least 1 month prior to participation in the study;

Key exclusion criteria (11 listed)

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
History of known or suspected Clostridium difficile infection;
History of seizure disorders;
Positive urine drug/alcohol testing at screening or check-in (Day -1);
Positive testing for HIV, HBsAg or HCV;

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
SPR741400 mg IV over 1 hour	Drug	SPR741/Aztreonam (N=9), SPR741/Ceftazidime (N=9), SPR741/Piperacillin/tazobactam (N=9)
Ceftazidime1.0 gram IV over 1 hour	Drug	SPR741/Ceftazidime (N=9)
Piperacillin/tazobactam4.5 grams IV over 1 hour	Drug	SPR741/Piperacillin/tazobactam (N=9)
Aztreonam1.0 gram IV over 1 hour	Drug	SPR741/Aztreonam (N=9)

Primary outcome

Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Pharmacokinetics: Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Pharmacokinetics: Time to maximum concentration (Tmax)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Pharmacokinetics: Terminal Elimination Rate Constant (kel)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Pharmacokinetics: Terminal half-life (t1/2)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Pharmacokinetics: Terminal clearance (CL)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.
Pharmacokinetics: Volume of distribution (Vd)
Time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8
Blood draws will be taken pre-dose (within 10 minutes), 30 minutes following the start of infusion, end of infusion and at 75, 90, 105, and 120 minutes, 4, 8, 12, and 24 hours following start of infusion.

15 secondary outcomes

Safety measures: adverse events (AEs)
Time frame: Day -1 to Day 9
Safety measures: Summary of type and frequency of concomitant medication
Time frame: Day -1 to Day 9
Safety measures: change in temperature (C/F)
Time frame: Day -1 to Day 9
Safety measures: change in blood pressure (mmHg)
Time frame: Day -1 to Day 9
Safety measures: change in heart rate (beats per minute)
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant physical exam findings
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (RR Interval)
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (P wave)
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (PR Interval)
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (QRS)
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (ST Segment)
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant changes in electrocardiogram parameter (T Wave)
Time frame: Day -1 to Day 9
Safety measures:abnormal, clinically significant changes in urinalysis from baseline to end of study
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant hematology changes from baseline to end of study
Time frame: Day -1 to Day 9
Safety measures: abnormal, clinically significant serum chemistry changes from baseline to end of study
Time frame: Day -1 to Day 9

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
Derived from this study: PubMed 31262767Eckburg PB, Lister T, Walpole S, Keutzer T, Utley L, Tomayko J, Kopp E, Farinola N, Coleman S. Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741, an Intravenous Potentiator, after Single and Multiple Ascending Doses and When Combined with beta-Lactam Antibiotics in Healthy Subjects. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00892-19. doi: 10.1128/AAC.00892-19. Print 2019 Sep.
Individual participant dataSharing planned: No

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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.

Annelize Koch, MBChB principal investigator

Simbec Research

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 SPR741, Ceftazidime and Piperacillin/tazobactam in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United Kingdom.

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 14 inclusion and 11 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 5 Jan 2018. 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 Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pharmacokinetics: Maximum concentration (Cmax) (time frame: Days 1 to 2, Days 4 to 5, Days 7 to 8). The study lists 8 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 NCT03376529, 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 5 Jan 2018.