A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05966688

Run by

Spero Therapeutics

People needed

39

Starts

2023-08-04

Expected to finish

2024-02-04

Last updated by the study team

2024-03-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.]

Where it is running

• Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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