Clinical trial NCT05966688: A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants
Official title: A Phase 1 Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Spero Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: It is anticipated that participants will enroll one after another in each arm of this study.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

\[Note: Other inclusion and exclusion criteria as per protocol may apply.\]

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Study Drug
timeFrame: Pre-dose and at multiple time points post-dose up to Day 8
measure: Time to Attain Maximum Plasma Concentration (tmax) for Study Drug
timeFrame: Pre-dose and at multiple time points post-dose up to Day 8
measure: Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-τ) for Study Drug
timeFrame: Pre-dose and at multiple time points post-dose up to Day 8
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From the first dose of study drug through follow-up Day 13
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
Study officials:
References: