Healthy VolunteersPhase 1NCT05966688
A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants
A Phase 1 study testing SPR720, Azithromycin and Ethambutol in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720, azithromycin, and ethambutol, administered separately and co-administered, in healthy adult 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 Volunteers
- What is being tested?
- SPR720, Azithromycin and Ethambutol
- 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
- 4 Aug 2023to 4 Feb 2024
- 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
- Body mass index (BMI) between ≥18.0 and ≤32.0 kilograms per meter square (kg/m^2) and weight between 50.0 and 100.0 kilograms (kg) (inclusive) at the Screening visit.
- Medically healthy without clinically significant medical history, abnormalities in physical examination, laboratory tests, vital signs, or electrocardiogram (ECG) at the Screening visit.
- Has suitable venous access for repeated blood sampling.
- Has ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) or products containing any of these from 48 hours prior to study drug administration until discharge from the clinical research unit (CRU).
Who cannot join
- Has a history of clinically significant acute illness or surgery within the previous 3 months prior to Screening Visit or Day -1.
- Has a known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.
- Has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas]). History of uncomplicated appendectomy ≥1 year prior to Screening Visit would not be considered exclusionary at the discretion of the Investigator.
- Is unable to swallow the dosage forms.
- Has received any other investigational medicinal product or participation in another investigational clinical study that included drug treatment within 30 days prior to Day 1 dose (based on the timing of the last Follow-up Visit for the previous study to Day 1 of the current study).
- [Note: Other inclusion and exclusion criteria as per protocol may apply.]
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
About this study
Official title: A Phase 1 Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Volunteers
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720, azithromycin, and ethambutol, administered separately and co-administered, in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- SPR720, Azithromycin, Ethambutol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPR720Drug
Multiple oral doses of SPR720 capsules.
AzithromycinDrug
Multiple oral doses of azithromycin.
EthambutolDrug
Multiple oral doses of ethambutol.
| Study group | Role | What they receive |
|---|---|---|
| SPR720 1000 mg | Experimental | Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days. Receives: Drug: SPR720 |
| Azithromycin 500 mg | Experimental | Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days. Receives: Drug: Azithromycin |
| Ethambutol 800 mg | Experimental | Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days. Receives: Drug: Ethambutol |
| SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg | Experimental | Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. Receives: Drug: SPR720; Drug: Azithromycin; Drug: Ethambutol |
| Azithromycin 500 mg + Ethambutol 800 mg | Experimental | Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. Receives: Drug: Azithromycin; Drug: Ethambutol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Study Drug
Measured: Pre-dose and at multiple time points post-dose up to Day 8
Time to Attain Maximum Plasma Concentration (tmax) for Study Drug
Measured: Pre-dose and at multiple time points post-dose up to Day 8
Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-τ) for Study Drug
Measured: Pre-dose and at multiple time points post-dose up to Day 8
Secondary outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From the first dose of study drug through follow-up Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Aug 2023
- Primary completion30 Jan 2024
- Study completion4 Feb 2024
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- It is anticipated that participants will enroll one after another in each arm of this study.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966688
- Sponsor's protocol ID
- SPR720-102
- Status last verified
- Feb 2024
- First submitted
- 20 Jul 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05966688
- Acronym / sponsor ID
- SPR720-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Spero TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 1 Aug 2023 (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.
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720, azithromycin, and ethambutol, administered separately and co-administered, in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- It is anticipated that participants will enroll one after another in each arm of this study.
| Arm | Type | Receives |
|---|---|---|
| SPR720 1000 mg | Experimental | Drug: SPR720Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days. |
| Azithromycin 500 mg | Experimental | Drug: AzithromycinHealthy participants will receive azithromycin 500 mg, orally, QD for 7 days. |
| Ethambutol 800 mg | Experimental | Drug: EthambutolHealthy participants will receive ethambutol 800 mg, orally, QD for 7 days. |
| SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg | Experimental | Drug: SPR720, Drug: Azithromycin, Drug: EthambutolHealthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. |
| Azithromycin 500 mg + Ethambutol 800 mg | Experimental | Drug: Azithromycin, Drug: EthambutolHealthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between ≥18.0 and ≤32.0 kilograms per meter square (kg/m^2) and weight between 50.0 and 100.0 kilograms (kg) (inclusive) at the Screening visit.
- Medically healthy without clinically significant medical history, abnormalities in physical examination, laboratory tests, vital signs, or electrocardiogram (ECG) at the Screening visit.
- Has suitable venous access for repeated blood sampling.
- Has ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) or products containing any of these from 48 hours prior to study drug administration until discharge from the clinical research unit (CRU).
Key exclusion criteria (6 listed)
- Has a history of clinically significant acute illness or surgery within the previous 3 months prior to Screening Visit or Day -1.
- Has a known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.
- Has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas]). History of uncomplicated appendectomy ≥1 year prior to Screening Visit would not be considered exclusionary at the discretion of the Investigator.
- Is unable to swallow the dosage forms.
- Has received any other investigational medicinal product or participation in another investigational clinical study that included drug treatment within 30 days prior to Day 1 dose (based on the timing of the last Follow-up Visit for the previous study to Day 1 of the current study).
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 |
|---|---|---|
| SPR720Multiple oral doses of SPR720 capsules. | Drug | SPR720 1000 mg, SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg |
| AzithromycinMultiple oral doses of azithromycin. | Drug | Azithromycin 500 mg, Azithromycin 500 mg + Ethambutol 800 mg, SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg |
| EthambutolMultiple oral doses of ethambutol. | Drug | Azithromycin 500 mg + Ethambutol 800 mg, Ethambutol 800 mg, SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Study Drug
Time frame: Pre-dose and at multiple time points post-dose up to Day 8
Time to Attain Maximum Plasma Concentration (tmax) for Study Drug
Time frame: Pre-dose and at multiple time points post-dose up to Day 8
Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-τ) for Study Drug
Time frame: Pre-dose and at multiple time points post-dose up to Day 8
1 secondary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From the first dose of study drug through follow-up Day 13
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 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
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 SPR720, Azithromycin and Ethambutol 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 4 inclusion and 6 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 4 Mar 2024. 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?
Maximum Observed Plasma Concentration (Cmax) of Study Drug (time frame: Pre-dose and at multiple time points post-dose up to Day 8). 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 4 Mar 2024.