A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05966688
- Lead Sponsor
- Spero Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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.]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg Ethambutol Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. Azithromycin 500 mg Azithromycin Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days. SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg SPR720 Healthy 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 Ethambutol Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. Ethambutol 800 mg Ethambutol Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days. SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg Azithromycin Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. SPR720 1000 mg SPR720 Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days. Azithromycin 500 mg + Ethambutol 800 mg Azithromycin Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.
- Primary Outcome Measures
Name Time Method 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 Time to Attain Maximum Plasma Concentration (tmax) for Study Drug Pre-dose and at multiple time points post-dose up to Day 8
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) From the first dose of study drug through follow-up Day 13
Trial Locations
- Locations (1)
Medpace Clinical Pharmacology Unit
🇺🇸Cincinnati, Ohio, United States