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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPR720 1000 mg | Experimental | Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days. |
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| Azithromycin 500 mg | Experimental | Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days. |
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| Ethambutol 800 mg | Experimental | Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days. |
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| SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg | Experimental | Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. |
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| Azithromycin 500 mg + Ethambutol 800 mg | Experimental | Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPR720 | Drug | Multiple oral doses of SPR720 capsules. |
|
| 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-Ï„) for Study Drug | Pre-dose and at multiple time points post-dose up to Day 8 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
[Note: Other inclusion and exclusion criteria as per protocol may apply.]
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | United States |
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It is anticipated that participants will enroll one after another in each arm of this study.
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| Azithromycin | Drug | Multiple oral doses of azithromycin. |
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| Ethambutol | Drug | Multiple oral doses of ethambutol. |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D004977 | Ethambutol |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
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