Healthy Volunteers
Conditions
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.
Interventions
DRUGSPR720
Multiple oral doses of SPR720 capsules.
DRUGAzithromycin
Multiple oral doses of azithromycin.
DRUGEthambutol
Multiple oral doses of ethambutol.
Sponsors
Spero Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
It is anticipated that participants will enroll one after another in each arm of this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Attain Maximum Plasma Concentration (tmax) for Study Drug | Pre-dose and at multiple time points post-dose up to Day 8 |
| Maximum Observed Plasma Concentration (Cmax) of Study Drug | 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 | Pre-dose and at multiple time points post-dose up to Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From the first dose of study drug through follow-up Day 13 |
Countries
United States
Outcome results
None listed