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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: SPR720
* Drug: Azithromycin
* Drug: Ethambutol


Participation Criteria
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Eligibility Criteria
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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.]

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: It is anticipated that participants will enroll one after another in each arm of this study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPR720 1000 mg<br>Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days. | Drug: SPR720<br>* Multiple oral doses of SPR720 capsules.<br>|
| Experimental: Azithromycin 500 mg<br>Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days. | Drug: Azithromycin<br>* Multiple oral doses of azithromycin.<br>|
| Experimental: Ethambutol 800 mg<br>Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days. | Drug: Ethambutol<br>* Multiple oral doses of ethambutol.<br>|
| Experimental: SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg<br>Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. | Drug: SPR720<br>* Multiple oral doses of SPR720 capsules.<br>Drug: Azithromycin<br>* Multiple oral doses of azithromycin.<br>Drug: Ethambutol<br>* Multiple oral doses of ethambutol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) |  | From the first dose of study drug through follow-up Day 13 |