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

Spero Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05966688

SPR720-102

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.]

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 5 patient groups

SPR720 1000 mg

Experimental group

Description:

Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days.

Treatment:

Drug: SPR720

Azithromycin 500 mg

Experimental group

Description:

Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days.

Treatment:

Drug: Azithromycin

Ethambutol 800 mg

Experimental group

Description:

Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days.

Treatment:

Drug: Ethambutol

SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg

Experimental group

Description:

Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.

Treatment:

Drug: Azithromycin

Drug: Ethambutol

Drug: SPR720

Azithromycin 500 mg + Ethambutol 800 mg

Experimental group

Description:

Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.

Treatment:

Drug: Azithromycin

Drug: Ethambutol