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Healthy ParticipantsPhase 1NCT06727136

A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants

A Phase 1 study testing TBP-PI-HBr in people with Healthy Participants, run by Spero Therapeutics 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 main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
TBP-PI-HBr
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
20 Nov 2024to 22 Apr 2025
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

  • Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
  • Body weight considering body mass index (BMI) within the range of 18 to 32 kilogram per meter square (kg/m^2), inclusive.
  • Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 55 years of age inclusive, at the time of signing the informed consent.

Who cannot join

  • History or presence of/significant history of or current cardiovascular (CV), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or study procedures or interfering with the interpretation of data.
  • Past or intended use of over-the-counter or prescription medication including herbal medications within 28 days prior to dosing, with the exception of supplemental vitamins, hormonal medications (contraceptives or hormone-replacement therapy), or occasional oral acetaminophen (not to exceeding 2 g total daily dose).
  • Current enrollment or past participation in another investigational/observational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days, or 5 half-lives whichever is longer.
  • Positive COVID-19 screening test using PCR or antigen assay at Day -1
  • Donation of, or significant blood loss of, more than 500 mL of blood within 56 days prior to dosing.
  • Receipt of a blood transfusion within 1 year prior to enrollment or plasma donation within 7 days prior to dosing.
  • QTc >450 msec.
  • Note: Other inclusion/exclusion criteria may also apply

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical Facility, Salt Lake City

    Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study to Characterize Single and Repeat Dose Pharmacokinetics (Including Food Effect) of Tebipenem-pivoxil-hydrobromide and Its Major Metabolite (SPR1349) in Healthy Participants

The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.

Being tested
TBP-PI-HBr

What participants receive

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

  • TBP-PI-HBrDrug

    Also called SPR994

    TBP-PI-HBr film-coated immediate-release tablets

Study groups in NCT06727136
Study groupRoleWhat they receive
Part A: Cohort 1ExperimentalParticipants will receive TBP-PI-HBr, 900 milligrams (mg) tablets orally, as a single dose under fasted condition on Day 1.
Receives: Drug: TBP-PI-HBr
Part A: Cohort 2 (Fasted/Fed)ExperimentalParticipants will receive TBP-PI-HBr, 1200 mg, tablets, orally, as a single dose under fasted and fed conditions on Day 1 and Day 3, as per the assigned crossover sequence.
Receives: Drug: TBP-PI-HBr
Part B: Cohort 3ExperimentalParticipants will receive TBP-PI-HBr, 600 mg, orally as a single dose on Day 1, followed by 9 doses every 6 hours from Day 3 through Day 5. (first and ninth dose will be given under fasted conditions).
Receives: Drug: TBP-PI-HBr

What is being measured

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

  1. Part A and B: Maximum Observed Concentration (Cmax) of TBP in Plasma and Blood

    Measured: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  2. Part A and B: Time to Cmax (Tmax) of TBP in Plasma and Blood

    Measured: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  3. Part A and B: Area Under the Concentration-Time Curve (AUC) Extrapolated to Infinity [AUC(0-inf)] of TBP in Plasma and Blood

    Measured: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  4. Part A and B: AUC From Time Zero to the Time of the Last Evaluable Concentration [AUC(0-t)] of TBP in Plasma and Blood

    Measured: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  5. Part A and B: Amount Excreted in Urine (Ae) of TBP

    Measured: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  6. Part A and B: Fraction of Dose Excreted in Urine (Fe) of TBP

    Measured: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  7. Part B: AUC From Time Zero to 6 Hours Post-dose AUC(0-6) of TBP in Plasma and Blood

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  8. Part B: Ae of SPR1349

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  9. Part B: Fe of SPR1349

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

Secondary outcomes (8)

  1. Part B: Tmax of SPR1349 in Plasma

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  2. Part B: Cmax of SPR1349 in Plasma

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  3. Part B: AUC(0-inf) of SPR1349 in Plasma

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  4. Part B: AUC(0-t) of SPR1349 in Plasma

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  5. Part B: AUC(0-6) of SPR1349 in Plasma

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  6. Part B: Plasma AUC Ratio of SPR1349 to TBP

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  7. Part B: Ae Ratio of SPR1349 to TBP

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 7

  8. Parts A and B: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 to Day 21

Timeline

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

  1. First posted10 Dec 2024
  2. Study start20 Nov 2024
  3. Primary completion22 Apr 2025
  4. Study completion22 Apr 2025

Resources

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
Model description
The study involves 2 parts (A and B) and 3 cohorts (Cohort 1, 2 and 3) of which Cohort 2 has a crossover design.
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06727136
Sponsor's protocol ID
SPR994-110
Status last verified
May 2025
First submitted
6 Dec 2024
Last updated
20 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TBP-PI-HBr in people with Healthy Participants, 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 3 inclusion and 8 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 20 May 2025. 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?

Part A and B: Maximum Observed Concentration (Cmax) of TBP in Plasma and Blood (time frame: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7). 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 NCT06727136.

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 20 May 2025.

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