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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966688
• Other study ID #: SPR720-102
• Status: Completed
• Phase: Phase 1
• Start date: August 4, 2023
• Est. completion date: February 4, 2024

Study information

• Verified date: February 2024
• Source: Spero Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 4, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.]

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SPR720
Multiple oral doses of SPR720 capsules.
• Azithromycin
Multiple oral doses of azithromycin.
• Ethambutol
Multiple oral doses of ethambutol.

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology Unit	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Spero Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Study Drug		Pre-dose and at multiple time points post-dose up to Day 8
Primary	Time to Attain Maximum Plasma Concentration (tmax) for Study Drug		Pre-dose and at multiple time points post-dose up to Day 8
Primary	Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-t) for Study Drug		Pre-dose and at multiple time points post-dose up to Day 8
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)		From the first dose of study drug through follow-up Day 13