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

NCT05966688 | Completed Phase 1 FDA Drug

• 1 other identifier: SPR720-102
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  From the first dose of study drug through follow-up Day 13

Study Arms (5)

SPR720 1000 mg

EXPERIMENTAL

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

Drug: SPR720

Azithromycin 500 mg

EXPERIMENTAL

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

Drug: Azithromycin

Ethambutol 800 mg

EXPERIMENTAL

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

Drug: Ethambutol

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.

Drug: SPR720; Drug: Azithromycin; Drug: Ethambutol

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.

Drug: Azithromycin; Drug: Ethambutol

Interventions

SPR720 DRUG

Multiple oral doses of SPR720 capsules.

SPR720 1000 mg; SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg

Azithromycin DRUG

Multiple oral doses of azithromycin.

Azithromycin 500 mg; Azithromycin 500 mg + Ethambutol 800 mg; SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg

Ethambutol DRUG

Multiple oral doses of ethambutol.

Azithromycin 500 mg + Ethambutol 800 mg; Ethambutol 800 mg; SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Spero Therapeutics: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Interventions

Azithromycin; Ethambutol

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ethylenediamines; Diamines; Polyamines; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: It is anticipated that participants will enroll one after another in each arm of this study.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: August 4, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 4, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)