Healthy VolunteersPhase 1NCT04421885
Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
A Phase 1 study testing Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference and Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United States.
Trial summary
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects. 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?
- Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference and Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 29 Jul 2020
- 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, male or female, 18 to 55 years of age
- Continuous non-smoker.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs.
- Has suitable venous access for repeated blood sampling.
- A female of childbearing potential must agree to abstain from sexual activity that could lead to pregnancy.
- A female of non-childbearing potential.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected to have during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease.
- History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History of significant allergic disease requiring treatment.
- History or presence of alcoholism or drug abuse.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
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- History of known genetic metabolism anomaly associated with carnitine deficiency.
- Female subjects with a positive pregnancy test or who are lactating.
- Positive urine drug or alcohol results.
- Positive results for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- QTcF interval is > 460 msec (males) or > 470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at the screening visit.
- Estimated creatinine clearance < 80 mL/min at the screening visit.
- Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover, Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference, Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - ReferenceDrug
600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - TestDrug
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.
| Study group | Role | What they receive |
|---|---|---|
| A: TBPM-PI-HBr (Reference - fasted) | Experimental | 600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions. Receives: Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference |
| B: TBPM-PI-HBr (Test - fasted) | Experimental | 600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions. Receives: Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test |
| C: TBPM-PI-HBr (Test - fed) | Experimental | 600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fed conditions. Receives: Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve extrapolated to infinity (AUC0-∞).
Measured: 24h (Day 2) post dose (Arms: A, B, C)
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
Measured: 24h (Day 2) post dose (Arms: A, B, C)
Maximum plasma concentration (Cmax).
Measured: 24h (Day 2) post dose (Arms: A, B, C)
Secondary outcomes (12)
Time to the maximum plasma concentration (Tmax).
Measured: 24h (Day 2) post dose (Arms: A, B, C)
Terminal elimination half-life (t½).
Measured: 24h (Day 2) post dose (Arms: A, B, C)
Apparent total body clearance (CL/F)
Measured: 24h (Day 2) post dose (Arms: A, B, C)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
Measured: 24h (Day 2) post dose (Arms: A, B, C)
Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.
ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.
Measured: 12 to 14 days after the last dose of study drug
Area under the curve extrapolated to infinity (AUC0-∞).
TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Measured: 24h (Day 2) post dose (Arms: B, C)
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Measured: 24h (Day 2) post dose (Arms: B, C)
Maximum plasma concentration (Cmax).
TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Measured: 24h (Day 2) post dose (Arms: B, C)
Time to the maximum plasma concentration (Tmax).
TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Measured: 24h (Day 2) post dose (Arms: B, C)
Terminal elimination half-life (t½).
TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Measured: 24h (Day 2) post dose (Arms: B, C)
Apparent total body clearance (CL/F)
TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Measured: 24h (Day 2) post dose (Arms: B, C)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Measured: 24h (Day 2) post dose (Arms: B, C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020
- Primary completion11 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Melnick, Study director, Spero Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421885
- Sponsor's protocol ID
- SPR994-105
- Status last verified
- Aug 2020
- First submitted
- 4 Jun 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover, Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04421885
- Acronym / sponsor ID
- SPR994-105
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Spero TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 9 Jun 2020 (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.
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover
| Arm | Type | Receives |
|---|---|---|
| A: TBPM-PI-HBr (Reference - fasted) | Experimental | Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions. |
| B: TBPM-PI-HBr (Test - fasted) | Experimental | Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions. |
| C: TBPM-PI-HBr (Test - fed) | Experimental | Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, adult, male or female, 18 to 55 years of age
- Continuous non-smoker.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs.
- Has suitable venous access for repeated blood sampling.
Key exclusion criteria (13 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected to have during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease.
- History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History of significant allergic disease requiring treatment.
- History or presence of alcoholism or drug abuse.
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 |
|---|---|---|
| Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr. | Drug | A: TBPM-PI-HBr (Reference - fasted) |
| Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr. | Drug | B: TBPM-PI-HBr (Test - fasted), C: TBPM-PI-HBr (Test - fed) |
Primary outcome
Area under the curve extrapolated to infinity (AUC0-∞).
Time frame: 24h (Day 2) post dose (Arms: A, B, C)
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
Time frame: 24h (Day 2) post dose (Arms: A, B, C)
Maximum plasma concentration (Cmax).
Time frame: 24h (Day 2) post dose (Arms: A, B, C)
12 secondary outcomes
Time to the maximum plasma concentration (Tmax).
Time frame: 24h (Day 2) post dose (Arms: A, B, C)
Terminal elimination half-life (t½).
Time frame: 24h (Day 2) post dose (Arms: A, B, C)
Apparent total body clearance (CL/F)
Time frame: 24h (Day 2) post dose (Arms: A, B, C)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
Time frame: 24h (Day 2) post dose (Arms: A, B, C)
Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.
Time frame: 12 to 14 days after the last dose of study drug
Area under the curve extrapolated to infinity (AUC0-∞).
Time frame: 24h (Day 2) post dose (Arms: B, C)
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
Time frame: 24h (Day 2) post dose (Arms: B, C)
Maximum plasma concentration (Cmax).
Time frame: 24h (Day 2) post dose (Arms: B, C)
Time to the maximum plasma concentration (Tmax).
Time frame: 24h (Day 2) post dose (Arms: B, C)
Terminal elimination half-life (t½).
Time frame: 24h (Day 2) post dose (Arms: B, C)
Apparent total body clearance (CL/F)
Time frame: 24h (Day 2) post dose (Arms: B, C)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
Time frame: 24h (Day 2) post dose (Arms: B, C)
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 12 Aug 2020.
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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 Melnick study director
Spero Therapeutics
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 Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference and Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test 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 8 inclusion and 13 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 12 Aug 2020. 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?
Area under the curve extrapolated to infinity (AUC0-∞). (time frame: 24h (Day 2) post dose (Arms: A, B, C)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2020.