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OpenTrials
Completed

NCT Number: NCT05966688

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.]

Treatment and study plan

SPR720

Drug

Multiple oral doses of SPR720 capsules.

Azithromycin

Drug

Multiple oral doses of azithromycin.

Ethambutol

Drug

Multiple oral doses of ethambutol.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Study Drug

    Time frame: Pre-dose and at multiple time points post-dose up to Day 8

  2. Time to Attain Maximum Plasma Concentration (tmax) for Study Drug

    Time frame: Pre-dose and at multiple time points post-dose up to Day 8

  3. Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-τ) for Study Drug

    Time frame: 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)

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

Sponsors and collaborators

Lead sponsor

Spero Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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