Status:
COMPLETED
A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants
Lead Sponsor:
Spero Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
- 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
- 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).
- \[Note: Other inclusion and exclusion criteria as per protocol may apply.\]
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05966688
Start Date
August 4 2023
End Date
February 4 2024
Last Update
March 4 2024
Active Locations (1)
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1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227