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

NCT ID: NCT05966688

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2024-02-04

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPR720 1000 mg

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

Group Type: EXPERIMENTAL

SPR720

Intervention Type: DRUG

Multiple oral doses of SPR720 capsules.

Azithromycin 500 mg

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

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

Multiple oral doses of azithromycin.

Ethambutol 800 mg

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

Group Type: EXPERIMENTAL

Ethambutol

Intervention Type: DRUG

Multiple oral doses of ethambutol.

SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg

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

Group Type: EXPERIMENTAL

SPR720

Intervention Type: DRUG

Multiple oral doses of SPR720 capsules.

Azithromycin

Intervention Type: DRUG

Multiple oral doses of azithromycin.

Ethambutol

Intervention Type: DRUG

Multiple oral doses of ethambutol.

Azithromycin 500 mg + Ethambutol 800 mg

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

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

Multiple oral doses of azithromycin.

Ethambutol

Intervention Type: DRUG

Multiple oral doses of ethambutol.

Interventions

SPR720

Multiple oral doses of SPR720 capsules.

Intervention Type: DRUG

Azithromycin

Multiple oral doses of azithromycin.

Intervention Type: DRUG

Ethambutol

Multiple oral doses of ethambutol.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

SPR720-102

Identifier Type: -

Identifier Source: org_study_id