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: Drug: Azithromycin; Drug: SPR720; Drug: Ethambutol

• 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

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Study Start: 2023-08-04
• Primary Completion: 2024-01-30
• Status Verified: 2024-02
• Study Completion: 2024-02-04
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

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