Healthy VolunteersPhase 1NCT04710407
Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
A Phase 1 study testing TBPM-PI-HBr in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United States.
Trial summary
To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TBPM-PI-HBr
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 10 Mar 2021
- 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
- Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening
- BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)
- Willing and able to provide written informed consent; Willing and able to comply with all study assessments and adhere to the protocol schedule
- Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis
- Have suitable venous access for blood sampling
Who cannot join
- History of seizure disorders
- Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV);
- Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
- Presence of the following symptoms at screening or within 14 days prior to screening or Check-in (Day -1)
- Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)
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- Difficulty breathing
- Cough
- Sore throat
- New or recent loss of taste or smell
- Nausea, vomiting or diarrhea;
- Close contact with anyone who tested positive for SARS-CoV-2 infection within 14 days prior to screening or Check-in (Day -1);
- Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females
- Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including:
- White blood cell count < 3,000/mm3, hemoglobin < 11g/dL;
- Absolute neutrophil count <1,200/mm3, platelet count <120,000/mm3;
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory;
- History of substance abuse or alcohol abuse
- Use of tobacco/nicotine- or marijuana-containing products (including vaping products) within 12 months prior to screening;
- Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-center, Open-label Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- TBPM-PI-HBr
- Keywords
- pharmacokinetics, TBPM-PI-HBr, tebipenem, alveolar macrophages (AM), epithelial lining fluid (ELF), intrapulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBPM-PI-HBrDrug
Also called TBPM-PI-HBr oral capsule, SPR994
TBPM-PI-HBr (2 x 300mg tablets) a total of five doses
| Study group | Role | What they receive |
|---|---|---|
| TBPM-PI-HBr | Experimental | Healthy subjects meeting eligibility criteria will receive a total of five doses of TBPM-PI-HBr 600 mg orally every 8 hours. Receives: Drug: TBPM-PI-HBr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK and lung penetration of SPR859 following multiple doses
Plasma PK parameters will include the area under the curve (AUC) from time zero to the last quantifiable sample (AUC0-t), AUC from time zero to end of dosing interval (AUC0-8). The AUC0-8 values for ELF and AM will be determined. The ratios of the AUC0-8 of ELF to the AUC0-8 of plasma and the AUC0-8 of AM to the AUC0-8 of plasma will be calculated.
Measured: Day 1 to Day 3
Plasma PK and lung penetration of SPR859 following multiple doses
Plasma PK parameters will include the maximum concentration (Cmax), minimum concentration (Cmin), time to Cmax (tmax), and the terminal-phase half-life (t1/2).
Measured: Day 1 to Day 3
Secondary outcomes (4)
Safety and tolerability, including adverse events (AEs)
Frequency of adverse events by severity, seriouness, system organ class, preferred term and treatment group
Measured: Day 1 to Day 10
Safety and tolerability, including clinically significant changes from baseline in clinical laboratory values
Change from baseline in selected laboratory assays including WBC, hemoglobin, platelet count, liver function tests (AST, ALT, AP), blood urea nitrogen (BUN), serum creatinine (Cr), and estimated Cr clearance (based on Cockcroft-Gault formula), by treatment group
Measured: Day 1 to Day 10
Safety and tolerability, including physical examination
Change from baseline in vital signs
Measured: Day 1 to Day 10
Safety and tolerability, including ECG
Cardiac (12-Lead ECG) will be summarized at each scheduled time point using descriptive statistics
Measured: Day 1 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start7 Dec 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Responsible party
- Sponsor
- Investigators
- David Baratz, MD, Principal investigator, Pulmonary Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710407
- Sponsor's protocol ID
- SPR994-108
- Status last verified
- Mar 2021
- First submitted
- 4 Jan 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodvold KA, Gotfried MH, Gupta V, Ek A, Srivastava P, Talley A, Bruss J. Plasma and Intrapulmonary Concentrations of Tebipenem following Oral Administration of Tebipenem Pivoxil Hydrobromide to Healthy Adult Subjects. Antimicrob Agents Chemother. 2022 Jul 19;66(7):e0059022. doi: 10.1128/aac.00590-22. Epub 2022 Jun 28.
PubMed 35762796
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
- ClinicalTrials.gov ID
- NCT04710407
- Acronym / sponsor ID
- SPR994-108
- Conditions
- Healthy Volunteers
- Keywords
- pharmacokinetics, TBPM-PI-HBr, tebipenem, alveolar macrophages (AM), epithelial lining fluid (ELF), intrapulmonary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Spero TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 14 Jan 2021 (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.
To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBPM-PI-HBr | Experimental | Drug: TBPM-PI-HBrHealthy subjects meeting eligibility criteria will receive a total of five doses of TBPM-PI-HBr 600 mg orally every 8 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening
- BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)
- Willing and able to provide written informed consent; Willing and able to comply with all study assessments and adhere to the protocol schedule
- Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis
- Have suitable venous access for blood sampling
Key exclusion criteria (20 listed)
- History of seizure disorders
- Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV);
- Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
- Presence of the following symptoms at screening or within 14 days prior to screening or Check-in (Day -1)
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 |
|---|---|---|
| TBPM-PI-HBrAlso: TBPM-PI-HBr oral capsule, SPR994TBPM-PI-HBr (2 x 300mg tablets) a total of five doses | Drug | TBPM-PI-HBr |
Primary outcome
Plasma PK and lung penetration of SPR859 following multiple doses
Time frame: Day 1 to Day 3
Plasma PK parameters will include the area under the curve (AUC) from time zero to the last quantifiable sample (AUC0-t), AUC from time zero to end of dosing interval (AUC0-8). The AUC0-8 values for ELF and AM will be determined. The ratios of the AUC0-8 of ELF to the AUC0-8 of plasma and the AUC0-8 of AM to the AUC0-8 of plasma will be calculated.
Plasma PK and lung penetration of SPR859 following multiple doses
Time frame: Day 1 to Day 3
Plasma PK parameters will include the maximum concentration (Cmax), minimum concentration (Cmin), time to Cmax (tmax), and the terminal-phase half-life (t1/2).
4 secondary outcomes
Safety and tolerability, including adverse events (AEs)
Time frame: Day 1 to Day 10
Safety and tolerability, including clinically significant changes from baseline in clinical laboratory values
Time frame: Day 1 to Day 10
Safety and tolerability, including physical examination
Time frame: Day 1 to Day 10
Safety and tolerability, including ECG
Time frame: Day 1 to Day 10
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 16 Mar 2021.
- Derived from this study: PubMed 35762796Rodvold KA, Gotfried MH, Gupta V, Ek A, Srivastava P, Talley A, Bruss J. Plasma and Intrapulmonary Concentrations of Tebipenem following Oral Administration of Tebipenem Pivoxil Hydrobromide to Healthy Adult Subjects. Antimicrob Agents Chemother. 2022 Jul 19;66(7):e0059022. doi: 10.1128/aac.00590-22. Epub 2022 Jun 28.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
David Baratz, MD principal investigator
Pulmonary Associates
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 TBPM-PI-HBr in people with Healthy Volunteers, run by Spero Therapeutics 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 5 inclusion and 20 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 16 Mar 2021. 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?
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?
Plasma PK and lung penetration of SPR859 following multiple doses (time frame: Day 1 to Day 3). The study lists 2 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 NCT04710407, 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 16 Mar 2021.